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UMDNS_CODE_(欧盟通用医疗器械编号)

UMDNS_CODE_(欧盟通用医疗器械编号)
UMDNS_CODE_(欧盟通用医疗器械编号)

UMDNS

CODE

UMDNS TERM English

10003Binders,Abdominal

10012Testers,Achilles Reflex

10014Acupuncture Kits

10024Adaptometers

10025Adenotomes

10026Adhesive Strips

10028Adhesive Strips,Hypoallergenic

10029Adhesive Strips,Waterproof

10030Tapes,Adhesive

10031Tapes,Adhesive,Hypoallergenic

10032Tapes,Adhesive,Waterproof

10033Adhesive Tape Removers

10034Adhesives

10035Adhesives,Aerosol

10036Adhesives,Liquid

10037Stools,Adjustable

10045Aerators,Ethylene Oxide

10046Aerosol Generators

10051Air Samplers

10053Airways

10056Airways,Esophageal Obturating

10057Airways,Nasopharyngeal

10058Airway Obstruction Removal Devices,

Emergency

10059Airways,Oropharyngeal

10077Alloys,Dental

10082Amalgamators

10085Ambulances

10086Ambulation Support Units

10088Amnioscopes

10089Amniotomes

10098Ampule Openers

10123Breathing Circuit Adapters

10124Anesthesia Kits

10125Anesthesia Kits,Brachial Plexus

10126Anesthesia Kits,Caudal

10127Anesthesia Kits,Epidural

10128Anesthesia Kits,Glossopharyngeal

10129Anesthesia Kits,Paracervical

10130Anesthesia Kits,Pudendal

10131Anesthesia Kits,Spinal

10134Anesthesia Units

10139Breathing Circuits,Anesthesia

10140Anesthesia Unit Absorbers,Carbon Dioxide 10142Anesthesia Unit Gas Scavengers

10144Anesthesia Unit Vaporizers

10145Anesthesia Unit Ventilators

10148Anesthesimeters

10149Stools,Anesthetist's

10152Angiotomes

10153Binders,Ankle

10155Anklets

10156Anoscopes

10164Apex Cardiographs

10168Applanometers

10171Jars,Applicator

10172Applicators

10173Applicators,Antiseptic

10174Applicators,Clip

10175Applicators,Eye

10176Applicators,Proctoscopic

10177Applicators,Tracheal

10182Baths,Arm

10183Covers,Arm Board UMDNS

CODE

UMDNS TERM English

10184Arm Boards

10185Arm Rests

10190Simulators,Arrhythmia

10197Arterioscopes

10198Arthroscopes

10199Articulators

10200Articulators,Cast

10201Articulators,Dental

10204Larynxes,Artificial

10208Aspirators

10211Canisters,Aspirator Collection

10212Aspirators,Dental

10214Aspirators,Infant

10215Aspirators,Low-Volume

10216Aspirators,Nasal

10217Aspirators,Surgical

10218Aspirators,Thoracic

10219Aspirators,Tracheal

10222Aspirators,Uterine

10223Aspirators,Wound

10224Ataxiagraphs

10225Atmocauteries

10226Atomizers

10228Audiometers

10229Audiometric Booths

10234Tourniquets,Pneumatic,Automatic Rotating 10239Autotransfusion Units

10243Baby Care Kits

10248Backrests

10261Balances

10263Balances,Electronic

10264Balances,Mechanical

10266Ballistocardiographs

10274Bandages

10276Bandages/Dressings,Adhesive

10278Adhesive Strips,Butterfly

10279Bandages,Elastic

10281Bandages,Gauze

10284Bandages,Pressure

10286Bandages,Scultetus

10288Bandages,Self-Adherent

10289Bandages,Traction

10291Bandages,Tubular

10297Metabolic Carts

10298Basin Stands

10302Bassinets

10304Bath Boots

10306Pillows,Bath

10316Bathtubs,Portable

10326Bed Boards

10328Bed Cradles

10334Cleaners,Bedpan

10335Covers,Bedpan

10336Racks,Bedpan

10338Warmers,Bedpan

10339Bedpans

10340Bedpans,Fracture

10341Bedrails

10342Beds

10345Beds,Circle Electric

10347Beds,Electric

10348Beds,Flotation Therapy

10351Beds,Fluoroscopic

10353Beds,Hydraulic

UMDNS

CODE

UMDNS TERM English

10356Beds,Labor

10357Beds,Mechanical

10360Beds,Orthopedic

10362Beds,Pediatric

10363Beds,Rocking

10368Stools,Bedside

10369Behavioral Therapy Units

10382Bibs

10383Ergometers,Bicycle

10385Exercisers,Bicycle

10386Bile Collection Bags

10396Biofeedback Systems

10397Biological Monitoring Systems 10401Biopsy Kits

10403Biopsy Kits,Ultrasonic Aspiration 10405Bite Blocks

10406Irrigation Kits,Bladder

10408Jars,Blade

10414Warmers,Blanket

10415Blankets

10416Blankets,Aluminized Rescue 10417Blankets,Infant

10421Blood Administration Sets

10425Blood Culture Kits

10426Blood Donor Sets

10429Blood-Flow Detectors,Ultrasonic 10430Flowmeters,Blood

10431Flowmeters,Blood,Electromagnetic 10432Flowmeters,Blood,Ultrasonic 10438Sampling Kits,Blood Gas

10440Lancets,Blood

10446Sampling Kits,Blood

10447Warmers,Blood/Solution

10455Cutters,Bone

10456Blades,Bone Cutting

10458Drivers,Bone Staple

10459Bone Wax

10479Brassieres

10480Brassieres,Maternity

10481Brassieres,Surgical

10483Binders,Breast

10484Breast Pads

10485Pumps,Breast

10486Breathing Bags

10491Bronchoscopes

10492Spirometers,Bronchial

10500Brushes

10502Brushes,Bur Cleaning

10503Brushes,Denture

10505Brushes,Eye

10506Brushes,Gingival

10507Brushes,Surgical Scrub

10509Brushes,Tracheal Tube

10510Bubble Detectors

10511Traps,Bubble

10516Burn Kits

10519Burs

10520Burs,Cranial

10521Burs,Dental

10522Burs,Podiatric

10526Cabinets

10529Cabinets,Anesthesia

10531Cabinets,Bedside

10532Cabinets,Dental UMDNS

CODE

UMDNS TERM English

10534Cabinets,Instrument

10535Cabinets,Medicine

10536Cabinets,Narcotic Control

10538Cabinets,Treatment,Ultraviolet 10540Cabinets,Warming

10541Cabinets,Pass Box,X-ray

10542Straps,Cable

10546Calipers

10547Calipers,Skinfold,Manual

10548Caloric Irrigation Units

10549Cameras

10551Cameras,Fundus

10552Cameras,Identification

10555Cameras,Newborn

10558Cameras,Oscilloscope

10559Cameras,Surgical

10560Canes

10561Cannulae

10564Cannulae,Arterial

10566Cannulae,Aspirating

10567Cannulae,Brain

10569Cannulae,Coronary Artery

10571Cannulae,Ear

10572Cannulae,Epidural

10573Cannulae,Eye

10574Cannulae,Eye,Cyclodialysis

10575Cannulae,Eye,Lacrimal

10576Cannulae,Femoral

10578Cannulae,Sinus

10580Cannulae,Uterine

10581Cannulae,Vena Caval

10582Cannulae,Venous

10588Carbon Dioxide Analyzers

10598Catheterization Kits,Cardiac

10608Cardiac Compression Boards

10613Cardiac Output Units

10614Cardiac Output Units,Direct Fick 10615Cardiac Output Units,Thermal Dilution 10617Cardiodynameters

10634Washers,Cart

10635Carts

10636Carts,Anesthetist's

10641Carts,Instrument

10642Carts,Isolation

10644Carts,Medication

10646Carts,Orthopedic Supply

10647Carts,Resuscitation

10650Carts,Traction

10655Cast Cutters

10656Cast Cutter Vacuums

10662Casting Units,Dental

10665Cast Material

10667Cast Boots

10668Shoes,Cast

10669Cast Stockinettes

10671Socks,Cast Toe

10672Cast Walking Heels

10673Cataract Extraction Units

10676Catheter Care Kits

10678Catheter Introducers

10685Catheters

10688Catheters,Angiography

10689Catheters,Arterial

10691Catheters,Arterial Micro-Flow

UMDNS

CODE

UMDNS TERM English

10694Catheters,Barium Enema

10695Catheters,Bartholin's Gland

10696Catheters,Biliary

10698Catheters,Cardiac

10700Catheters,Cardiac Balloon

10701Catheters,Cardiac Bypass

10702Catheters,Cardiac Percutaneous

10704Catheters,Cerebrospinal

10706Catheters,Coronary Perfusion

10709Catheters,DePezzer

10714Catheters,Embolectomy

10716Catheters,Esophageal Balloon

10717Catheters,Epidural

10718Catheters,Eustachian

10720Catheters,Urinary,Foley

10723Catheters,Hemostatic

10725Catheters,Intra-Aortic Balloon

10727Catheters,Intravenous,Peripheral

10729Catheters,Central Venous

10730Catheters,Irrigation

10731Catheters,Jejunostomy

10732Catheters,Mushroom

10734Catheters,Nelaton

10735Catheters,Nephrostomy

10736Catheters,Occlusion

10737Catheters,Olive Tip

10739Catheters,Perfusion

10741Catheters,Pericardium Drainage

10742Catheters,Peritoneal Dialysis

10746Catheters,Rectal

10747Catheters,Septostomy

10748Catheters,Single-Needle Hemodialysis 10749Catheters,Suction

10751Catheters,Suprapubic

10754Catheters,Cardiac Balloon,Thermal Dilution 10756Catheters,Thrombectomy

10759Catheters,Umbilical

10760Catheters,Umbrella

10761Catheters,Ureteral

10762Catheters,Urethral

10763Catheters,Urethral,Diagnostic

10764Catheters,Urinary

10765Catheters,Urinary,Condom

10767Catheters,Urinary,Irrigation

10769Catheters,Intracranial,Ventricular

10776Manometer Sets,Venous,Central/Peripheral 10778Centrifuges

10779Centrifuges,Microhematocrit

10780Centrifuges,Tabletop

10787Chairs

10788Chairs,Bath

10789Chairs,Blood Drawing

10790Chairs,Cardiac

10792Chairs,Dental

10794Chairs,Examination/Treatment,

Ear/Nose/Throat

10795Chairs,Flotation Therapy

10796Chairs,Geriatric

10797Chairs,Pediatric

10799Chairs,Podiatric

10801Chairs,Rehabilitation

10802Chairs,Shower

10810Recorders,Chart

10816Binders,Chest UMDNS

CODE

UMDNS TERM English

10817Drainage Systems,Pleural

10822Radiographic Units,Chest

10824Chisels

10825Chisels,Bone

10827Chisels,Mastoid

10828Chisels,Nasal

10829Chisels,Orthopedic

10831Choledochoscopes

10832Chromoradiometers

10833Chronaximeters

10838Circuit Breaker Testers

10839Circulatory Assist Units

10840Circulatory Assist Units,Cardiac

10846Circulatory Assist Units,Intra-Aortic Balloon 10847Circulatory Assist Units,Ventricular

10849Circulatory Assist Units,Venous Return 10858Circumcision Trays

10859Circumcision Trays,Disposable

10860Circumcision Trays,Reusable

10861Clamps

10864Clamps,Aorta

10865Clamps,Artery

10866Clamps,Bone

10867Clamps,Bronchus

10868Clamps,Bulldog

10869Clamps,Circumcision

10870Clamps,Hemorrhoidal

10871Clamps,Intestinal

10872Clamps,Patent Ductus

10873Clamps,Peripheral Vascular

10875Clamps,Tubing

10876Clamps,Umbilical

10894Clip Appliers

10895Clip Removers

10898Clips

10901Clips,Bandage

10902Clips,Drape

10904Clips,Instrument

10905Clips,Aneurysm

10906Clips,Iris

10907Clips,Nose

10908Clips,Penis

10909Clips,Scalp

10910Clips,Skin

10911Clips,Suture

10914Clips,Towel

10915Clips,Vena Caval

10916Clips,Wound

10918Clocks,Elapsed-Time

10932Cold Packs

10937Collars

10938Collars,Cervical

10941Collectors

10943Collectors,Sputum

10944Collectors,Urine

10950Colonoscopes

10951Coloscopes

10960Colposcopes

10961Commode Seats

10962Commodes

10964Compimeters

10965Compresses

10966Compresses,Gauze

10967Compresses,Moist Heat

UMDNS

CODE

UMDNS TERM English

10969Compression Units,Intermittent

10971Compressors

10972Compressors,Medical-Air

10977Computers

10980Computers,Cardiac Catheterization Laboratory 10981Computers,ECG Interpretation

10984Computers,Pulmonary Function Laboratory 10985Condoms

10986Aprons,Conductive

10990Testers,Conductivity

10992Testers,Conductivity,Floor and Equipment 10993Testers,Conductivity,Gown

10994Testers,Conductivity,Shoe

10995Cleaners,Contact Lens

10996Contact Lenses

11001Continuous Positive Airway Pressure Units 11003Contourographs

11009Controllers

11010Infusion Controllers

11017Cornish Hemostatic Wool

11023Correlators,Retinal

11024Corsets

11028Cotton Balls

11049Crib Tops

11052Cricothyreotomes

11058Dental Crowns,Preformed

11059Crushers

11060Crushers,Fascia

11062Crutch Pads

11063Crutches

11066Cryometers

11067Cryosurgical Units,General-Purpose

11068Cryosurgical Units,Ophthalmic

11071Cuff Inflators

11072Cuffs

11073Cuffs,Blood Pressure

11079Culdoscopes

11084Curets

11089Current Limiters,Patient Leads

11090Curtains,Cubicle,Reusable

11093Cushions

11095Cushions,Foot

11096Cushions,Ring

11097Cushions,Ring,Foam Rubber

11098Cushions,Ring,Inflatable

11099Cushions,Stool

11100Cushions,Wheelchair

11101Cuspidors

11111Cystometers

11112Cystoscopes

11113Cystitomes

11114Cystourethroscopes

11122Decapitation Instruments

11126Decompression Units,Abdominal

11127Defibrillator Analyzers

11129Defibrillator/Monitors

11130Defibrillator Paddle Pads

11132Defibrillators

11133Defibrillators,Internal

11134Defibrillators,Battery-Powered

11137Defibrillators,Line-Powered

11141Delivery Kits

11145Demineralizers

11150Cement,Dental UMDNS

CODE

UMDNS TERM English

11155Rubber Dams,Dental

11156Dental Engines

11158Dental Floss

11159Dental Foil,Gold

11160Dental Hand Instruments

11161Handpieces,Dental

11164Stools,Dental

11165Dental Delivery Units

11167Dentaphones

11168Dentifrice

11169Cups,Denture

11170Denture Cushions

11171Denture Repair Kits

11172Dentures,Preformed

11177Dermabrasion Units

11179Dermatomes

11182Dermohygrometers

11183Dermotherms

11184Desensitizers

11202Device Status Tags

11206Dialysate Conductivity Meters

11211Dialysate Delivery Systems,Multipatient 11213Dialysate Delivery Systems,Single-Patient 11218Hemodialysis Units

11219Hemodialysis Unit Air Bubble-Foam Detectors 11220Hemodialysis Unit Blood Pumps

11222Hemodialysis Unit Conductivity Monitors 11224Hemodialysis Unit Single-Needle Controllers 11225Hemodialysis Tubing Sets

11226Peritoneal Dialysis Units

11227Peritoneal Dialysis Unit Tubing Sets

11228Dialysis Unit Test Equipment

11230Dialyzers

11232Dialyzers,Hemodialysis

11233Dialyzers,Hemodialysis,Coil

11234Dialyzers,Hemodialysis,Hollow-Fiber

11235Dialyzers,Hemodialysis,Parallel-Plate 11237Diamond Rotary Instruments

11238Diapers

11239Diapers,Adult

11240Diapers,Pediatric

11244Diathermy Units

11245Diathermy Units,Microwave

11246Diathermy Units,Shortwave

11248Ultrasound Units,Physical Therapy

11253Dilatometers

11254Dilators

11255Dilators,Cardiac

11256Dilators,Common Duct

11257Dilators,Esophageal

11259Dilators,Lacrimal

11260Dilators,Nasal

11261Dilators,Pulmonary

11262Dilators,Rectal

11263Dilators,Tracheal

11264Dilators,Tubal

11265Dilators,Urethral

11266Dilators,Uterine

11267Dilators,Vaginal

11268Dilators,Vascular

11269Diopsimeters

11274Directoscopes

11278Disinfectors

11279Disinfecting Units,Liquid,Flexible Endoscope

UMDNS

CODE

UMDNS TERM English

11280Disinfectors,Pasteurization

11282Disks,Dental

11283Dispensers

11284Dispensers,Brush

11285Dispensers,Fluid

11287Unit-Dose Dispensers,Pill,Narcotic Control 11289Dissecting Kits

11290Dissectors

11291Distractors

11293Dolorimeters

11295Dosimeters,Radiation

11297Douche Kits

11298Douche Nozzles

11301Drainage Bags

11303Bottles,Drainage

11304Drains

11305Drains,Wound

11307Drains,T

11308Drains,Thoracic

11310Drains,Vent

11313Jars,Dressing

11314Dressing Kits

11315Dressings

11321Dressings,Aerosol

11322Dressings,Burn

11323Dressings,Foam

11324Dressings,Germicidal

11325Dressings,Nonadherent

11326Dressing Pads

11327Dressings,Roller Gauze

11328Dressings,Universal

11329Drills

11330Drills,Biopsy

11331Drills,Bone

11332Drills,Cannulated

11333Drills,Cervical

11334Perforators,Cranial,Automatic

11337Drills,Fingernail

11338Drills,Intramedullary

11339Drills,Middle Ear Surgery

11341Burs,Oral Surgery

11342Drills,Perforator

11345Driver/Extractors

11346Driver/Extractors,Bone Nail-Pin

11347Driver/Extractors,Bone Plate

11359Duodenoscopes

11365Dynamometers,Other

11367Dynamometers,Squeeze

11369Bougies,Ear

11370Droppers,Ear

11371Irrigation Kits,Ear

11374Ear Piercing Instruments

11375Ear Plugs

11376Syringes,Ear

11379ECG Monitor Analyzers

11381Simulators,ECG

11385Recorders,Echocardiographic

11387Echoencephalographs

11389Scanners,Ultrasonic,Ophthalmic

11391Eikonometers

11393Ejectors,Saliva

11394Elastomers,Silicone Rubber

11399Electrical Safety Analyzers

11401Electrobasographs UMDNS

CODE

UMDNS TERM English

11402Electrocardiocontourographs

11407Electrocardiographs

11410Electrocardiograph Cable Testers

11411Electrocardiographs,Multichannel

11413Electrocardiographs,Single-Channel

11418Electrocautery Units

11421Electrocautery Units,Battery-Powered

11422Electrocautery Units,Line-Powered

11425Gel,Electrode

11426Testers,Electrode

11429Electrode Straps

11431Electrodes,Blood Gas

11432Electrodes,Blood Gas,Carbon Dioxide 11433Electrodes,Blood Gas,Oxygen

11434Electrodes,Catheter Tip

11436Electrodes,Cystoscopic

11439Electrodes,Electrocardiographic

11440Electrodes,Electroencephalographic

11441Electrodes,Electromyographic

11442Electrodes,Electronystagmographic

11443Electrodes,Electrooculogram

11444Electrodes,Electroshock

11446Electrodes,Esophageal

11447Electrodes,Fetal Scalp

11452Electrodes,Nasopharyngeal

11453Electrodes,Neurological

11454Electrodes,Neuromuscular Stimulator

11458Leads,Pacemaker,Implantable Myocardial 11460Electrodes,Electroretinographic

11461Electrodes,Sweat Test

11467Electroencephalographs

11471Electrogoniometers

11473Electromanometers

11474Electromyographs

11479Electronystagmographs

11480Electrooculographs

11482Electroretinographs

11483Electrorheographs

11484Electroconvulsive Therapy Units

11485Electrosleep Units

11487Electrostatic Voltage Detectors

11489Electrosurgical Unit Analyzers

11490Electrosurgical Units

11493Electrosurgical Unit Adapters,Cable

11494Electrosurgical Unit Adapters,Hand Control 11496Cables/Leads,Electrosurgical Unit

11497Electrode Holders,Electrosurgical

11499Electrodes,Electrosurgical,Active,Hand-

Controlled

11500Electrodes,Electrosurgical,Return

11502Forceps,Electrosurgical

11503Electrotherapeutic Units

11504Elevators

11506Elevators,ENT

11507Elevators,Neurosurgical

11508Elevators,Orthopedic

11515Emergency Drug Kits

11522Basins,Emesis

11526Encephaloscopes

11529Endoradiographs

11530Endoradiosondes

11531Sampling Kits,Endometrial

11576Endoscopic Power Supplies

11577Endoscopic Power Supplies,Battery-Operated

UMDNS

CODE

UMDNS TERM English

11578Endoscopic Power Supplies,Line-Operated 11581Enema Bags

11582Enema Kits

11583Enema Tips

11585Ear/Nose/Throat Treatment Units

11587Enucleators

11588Alarms,Enuresis

11589Epilators

11592Ergometers

11597Bougies,Esophageal

11599Esophageal Coolers

11600Esophageal Motility Analyzers

11601Stethoscopes,Esophageal

11603Esophagoscopes

11604Esthesiometers

11606Droppers,Ether

11608Ethylene Oxide Analyzers

11614Evoked-Potential Units

11617Excavators,Endaural

11618Exchange Transfusion Kits

11620Exercise Stairs

11621Stools,Exercise

11623Exercisers

11625Exercisers,Arm

11627Exercisers,Chest

11628Exercisers,Finger

11629Exercisers,Hand

11630Exercisers,Leg and Ankle

11631Exercisers,Continuous Passive Motion 11633Quadriceps Boards

11634Exercisers,Respiratory

11636Exercisers,Shoulder

11638Exercisers,Trapeze

11652Charts,Eye

11653Cups,Eye

11654Droppers,Eye

11655Irrigation Kits,Eye

11657Masks,Eye

11659Masks,Eye,Phototherapy

11661Eye Pads

11663Shields,Eye

11667Eyeglasses

11675Enteral Feeding Bags

11677Enteral Feeding Kits

11684Fenestrometers

11692Fetal Heart Detectors

11695Fetal Heart Detectors,Phono

11696Fetal Heart Detectors,Ultrasonic

11700Fibrillators

11701Files

11702Files,Bone

11703Files,Callous

11704Filiforms

11710Filters

11711Filters,Air

11712Filters,Bacteria

11713Filters,Blood

11716Filters,Intravenous Tubing

11717Filters,Kidney Stone

11718Filters,Vena Cava

11719Finger Cots

11720Finger Protectors

11723First Aid Kits

11726Fittings/Adapters UMDNS

CODE

UMDNS TERM English

11727Fittings/Adapters,Pneumatic,DISS

11729Fittings/Adapters,Luer

11731Fittings/Adapters,Pneumatic,Quick-Connect 11736Flicker-Fusion Units

11740Floor Mats,Antibacterial

11744Flow Timers

11745Flow Totalizers

11746Flowmeters

11748Flowmeters,Gas

11751Dressings,Fluff

11757Radiographic/Fluoroscopic Units,General-Purpose

11758Radiographic/Fluoroscopic Units,Mobile 11761Fluxmeters

11769Foot Boards

11771Footstools

11772Footstools,Conductive

11773Footstools,Nonconductive

11774Forceps

11775Forceps,Biopsy

11777Forceps,Dressing

11779Forceps,Laparoscopic

11780Forceps,Epilation

11781Forceps,Fixation

11782Forceps,Gallbladder

11784Forceps,Hemostatic

11785Forceps,Intestinal

11787Forceps,Lung

11788Forceps,Obstetrical

11790Forceps,Specimen

11791Forceps,Sponge

11792Forceps,Sterilizer Transfer

11793Forceps,Stone Manipulation

11794Forceps,Suction

11797Forceps,Tissue

11798Forceps,Utility

11799Jars,Forceps

11802Forensic Evidence Kits

11803Forensic Evidence Kits,Sexual Assault 11814Fume Evacuators

11822Gags

11825Beta/Gamma Detectors

11835Carriers,Medical Device

11838Gas Cylinder Stands/Holders

11848Gas Sampling Units

11850Gasometers

11853Gastroduodenoscopes

11854Gastrographs

11856Gastroscopes

11857Gastroscopes,Flexible

11858Gastroscopes,Rigid

11859Gauze

11868Cups,Geriatric Feeding

11878Glove Processing Units

11879Gloves

11880Gloves,Autopsy

11882Gloves,Examination/Treatment

11883Gloves,Surgical

11884Gloves,Surgical,Hypoallergenic

11885Gloves,Utility

11893Goniometers

11894Gonioscopes

11895Gouges

11897Gowns

UMDNS

CODE

UMDNS TERM English

11898Gowns,Operating Room

11901Gowns,Operating Room,Disposable 11902Gowns,Operating Room,Reusable 11903Gowns,Patient

11904Gowns,Patient,Disposable

11905Gowns,Patient,Reusable

11908Grafts

11910Grafts,Bone

11912Grafts,Skin

11913Prostheses,Blood Vessel,Biological 11919Ground Fault Circuit Interrupter Testers 11920Ground Fault Circuit Interrupters

11923Grounding System Testers

11925Guide Wires

11927Guides

11930Guides,Drill

11931Guides,Gigli Saw

11933Guillotines

11934Guillotines,Adenoid

11935Guillotines,Tonsil

11937Gustometers

11939Clippers,Hair

11941Halogenated Anesthetics Analyzers 11947Hammers

11949Hammers,Neurological

11950Hammers,Percussion

11958Head Halters

11960Head Mirrors

11961Shields,Face

11962Head Tanks

11963Headlights

11964Headrests

11967Hearing Aids

11969Heart-Lung Bypass Units

11973Heat Exchangers,Heart-Lung Bypass 11974Oxygenators,Extracorporeal Bubble 11975Pulsatile Pressure Generators,Heart-Lung Bypass Unit

11977Simulators,Heart Sound

11978Heat Exchangers

11985Heating Pads

11988Pads,Circulating-Fluid,Localized

Heating/Cooling

11989Heating Pads,Electric

11991Heel Stirrups

11995Surgical Helmet Systems

11996Hemacytometers

12001Hemoperfusion Systems

12009His Bundle Detectors

12021Hoods

12022Hoods,Chemical Fume

12025Hoods,Isolation,Laminar Air Flow

12027Hoods,Oxygen

12028Hooks

12029Hooks,Cordotomy

12030Hooks,Ether

12031Hooks,Incus

12032Hooks,Intrauterine Device Removal 12033Hooks,Rhinoplastic

12034Hooks,Scleral Fixation

12035Hooks,Skin

12036Hooks,Strabismus

12037Hooks,Sympathectomy

12038Hooks,Tracheal UMDNS

CODE

UMDNS TERM English

12040Hot Packs

12042Bottles,Hot/Cold Water

12047Humidifiers

12050Humidifiers,Heated

12051Humidifiers,Nonheated

12059Hygrometers

12061Chambers,Hyperbaric

12066Hyperthermia Units,Radio-Frequency 12067Hypo/Hyperthermia Blankets

12068Hypo/Hyperthermia Units

12074Hypo/Hyperthermia Units,Central

12075Hypo/Hyperthermia Units,Mobile,General-Purpose

12076Chambers,Hypobaric

12078Hypothermia Units

12081Hysteroscopes

12082Ice Bags

12085Collars,Ice

12088Identification Bracelets

12093Immobilizers

12094Immobilizers,Ankle

12095Immobilizers,Arm

12096Immobilizers,Elbow

12097Immobilizers,Infant

12099Immobilizers,Knee

12101Immobilizers,Shoulder

12102Immobilizers,Wrist

12103Impedance Cardiographs

12108Incision and Drainage Kits

12109Incontinence Clamps

12110Linen Protection Pads

12111Incontinence Pants

12112Incubators

12113Incubators,Infant

12114Incubators,Infant,Transport

12128Inhalers,Aerosol

12129Injectors

12132Injectors,Medication/Vaccine,Syringe 12134Injectors,Thermal Dilution

12135Insect Sting Emergency Kits

12142Racks,Instrument

12143Trays,Instrument

12144Insufflators

12152Intracervical Devices

12155Intrauterine Balloons

12156Intrauterine Devices

12157Intravenous Administration Sets

12159Intravenous Administration Sets,Buret 12161Catheterization Kits,Intravenous

12162Intravenous Catheter-Needle Immobilizers 12168Counters,Intravenous Drop

12170Intravenous Extension Tubing Kits

12171Flowmeters,Intravenous

12172Intravenous Fluid Containers

12173Intravenous Hangers

12177Intravenous Poles

12184Ionized Air Generators

12185Iontophoresis Units

12199Testers,Isolated Power System

12200Chambers,Isolation

12222Keratomes

12223Kick Bucket Liners

12229Kinesthesiometers

12234Blades,Knife

UMDNS

CODE

UMDNS TERM English

12235Knife Handles

12236Knife Holders

12237Knife Needles

12239Knives

12240Knives,Amputating

12241Knives,Cataract

12242Knives,Commissurotomy

12243Knives,Dermatome

12244Knives,Dural Hook

12245Knives,Ear

12247Knives,Keratome

12248Knives,Meniscus

12249Knives,Microtome

12250Knives,Paraffin

12251Knives,Plaster

12252Knives,Scalpel

12253Knives,Skin Grafting

12254Knives,Sternum

12255Knives,Tonsil

12268Laminar Air Flow Units

12270Laminaria Tents

12276Lights,Examination

12278Lights,Infrared

12279Lights,Perineal Heat

12281Slit Lamps

12282Lights,Surgical

12283Lights,Ultraviolet

12284Lights,Ultraviolet,Germicidal

12291Laparoscopes

12292Tubes,Laryngectomy

12293Laryngoscopes

12294Laryngostroboscopes

12296Lasers

12299Lasers,Therapeutic

12300Lavage Units

12301Lavage Units,Colonic

12302Lavage Units,Corneal

12304Lavage Units,Dental/Oral

12305Lavage Units,Otorhinolaryngological

12306Lavage Units,Surgical

12311Leakage Current Meters

12313Baths,Leg

12315Leg Rests

12318Lens Expressors

12319Lens Loops

12321Lens Spoons

12322Lenses

12324Lenses,Intraocular

12326Lensometers

12327Lesion Generators

12329Lifts

12330Lifts,Patient Transfer

12331Lifts,Wheelchair,Vertical

12332Ligators

12335Ligators,Hemorrhoid

12336Ligature Carriers

12340Light Sources

12343Light Sources,Fiberoptic,Flexible Endoscopic 12345Light Sources,Fiberoptic

12346Light Sources,Flash

12347Lights

12351Lights,Dental

12352Lights,Dental,Intraoral

12361Line Isolation Monitors UMDNS

CODE

UMDNS TERM English

12364Linear Accelerators

12368Drapes,Surgical

12369Laundry Bags,Operating Room

12370Sheets,Operating Room

12374Lingual Palatal Bars

12377Lithometers

12379Lithotrites

12385Recorders,Long-Term

12386Recorders,Long-Term,Blood Pressure,

Portable

12387Recorders,Long-Term,ECG

12388Recorders,Long-Term,ECG,Portable 12389Recorders,Long-Term,EEG

12390Recorders,Long-Term,Oxygen

12391Recorders,Long-Term,Trend

12393Loops

12394Loops,Endarterectomy

12396Loops,Tracheal

12397Loops,Vascular

12398Drivers,Nail

12401Lubricating Jellies

12404Lumbar Puncture Kits

12405Belts,Lumbosacral

12408Simulators,Lung

12409Lymphangiographic Kits

12415Magnetic Units,Therapeutic

12416Magnetocardiographs

12417Magnetometers

12421Mallets

12423Mallets,Bone

12424Mallets,Dental

12425Radiographic Units,Mammographic

12429Mandrels

12432Manometers,Aneroid

12440Markers

12441Markers,Implantable Radiographic

12442Markers,Ocular

12443Markers,Skin

12447Masks

12448Masks,Air-Oxygen

12449Masks,Air-Oxygen,Aerosol Administration 12450Masks,Air-Oxygen,Nonrebreathing

12451Masks,Air-Oxygen,Partial Rebreathing 12452Masks,Air-Oxygen,Venturi

12453Masks,Anesthesia

12458Masks,Surgical

12459Masks,Tracheostomy

12460Masks,Tracheostomy,Aerosol Administration 12461Mass Screening Systems

12463Maternity Kits

12467Covers,Mattress

12468Covers,Mattress,Conductive

12469Covers,Mattress,Waterproof

12473Mattresses

12475Mattresses,Bed

12477Mattresses,Metabolic

12478Mattresses,Operating Table

12479Mattresses,Vacuum

12480Mattresses,Water

12499Mediastinoscopes

12500Medical Bags

12501Medical Chart Holders

12502Medical Chart Racks

12504Injectors,Medication/Vaccine

UMDNS

CODE

UMDNS TERM English

12505Cups,Medicine

12506Droppers,Medicine

12507Trays,Medicine

12510Mesh,Polymeric

12516Metal Detectors,Magnetic

12518Metal Detectors,Photographic

12519Metal Detectors,Ultrasonic

12521Extractors,Metal,Magnetic

12524Metreurynters

12529Microelectrode Amplifiers

12530Microelectrode Pullers

12531Microelectrodes

12533Microgasometers

12534Micromanipulators

12535Covers,Microscope

12536Microscopes

12537Microscopes,Corneal

12538Microscopes,Ear

12539Microscopes,Operating

12540Microwave Leakage Detectors

12542Midstream Collection Kits

12547Mirrors

12549Mirrors,Laryngeal

12550Mirrors,Middle Ear

12551Mirrors,Obstetrical

12552Mirrors,Posture

12553Mirrors,Speech

12554Tents,Mist

12557Tents,Mist,Face

12559Mitts,Patient

12560Mixing Slabs

12565Moist Heat Therapy Pack Conditioners 12566Moist Heat Therapy Packs

12570Moleskins

12575Apnea Monitors

12585Alarms,Bed Occupancy

12586Blood Gas Monitors

12588Blood Gas Monitors,Carbon Dioxide

12590Blood Gas Monitors,Oxygen

12592Oxygen Monitors,Transcutaneous

12597Cerebral Function Monitors

12599ECG Monitors

12601ECG Monitors,Arrhythmia

12602EEG Monitors

12606Environmental Monitors,Atmospheric Gas 12609Eye Movement Monitors

12610Fetal Monitors

12614Heart Rate Monitors

12618Heart Rate Monitors,R-Wave

12621Impedance Pneumograph Monitors

12634pH Monitors

12636Physiologic Monitoring Systems

12647Physiologic Monitoring Systems,Acute Care 12648Physiologic Monitoring Systems,Cardiac Catheterization

12649Physiologic Monitoring Systems,Stress

Exercise

12657Pulse Monitors

12660Radiation Monitors

12662Respiration Monitors

12672Temperature Monitors

12678Ventilation Monitors

12684Traps,Mucus

12689Myelogram Kits UMDNS

CODE

UMDNS TERM English

12690Myeloscopes

12692Myographs

12695Clippers,Nail

12696Extractors,Nail

12699Balloons,Nasal

12700Cannulae,Nasal Oxygen

12701Cannulae,Nasal Oxygen,Continuous Positive Airway Pressure

12702Catheters,Nasal Oxygen

12704Nasal Septum Buttons

12705Nasogastric Headbands

12706Nasographs

12709Nasopharyngoscopes

12710Nasoscopes

12711Nebulizer Testers

12712Nebulizers

12716Nebulizers,Heated

12719Nebulizers,Ultrasonic

12723Cleaners,Needle

12724Counters,Needle

12726Needle Holders

12727Needle Introducers

12729Needles

12730Needles,Acupuncture

12732Needles,Airway

12733Needles,Anesthesia

12734Needles,Biopsy

12736Needles,Blood-Collecting

12737Needles,Blunt

12738Needles,Cardiac

12739Needles,Cholangiographic

12740Needles,Dental

12741Needles,Dialysis

12744Needles,Eye

12745Needles,Hypodermic

12747Needles,Intra-Arterial

12748Needles,Intravenous

12750Needles,Pneumoperitoneal

12751Needles,Radiographic

12752Needles,Scalp-Vein Type

12753Needles,Spinal

12754Needles,Suture

12766Nippers,Malleus

12768Nitrous Oxide Analyzers

12774Droppers,Nose

12779Bottles,Infant Nursing

12784Observerscopes

12789Obturators

12791Oculoplethysmographs

12796Olfactometers

12799Cardiointegraphs

12800Oncometers

12804Ophthalmodiaphanoscopes

12805Ophthalmodiastimeters

12809Ophthalmographs

12810Ophthalmoleukoscopes

12811Ophthalmometers

12813Ophthalmometroscopes

12815Ophthalmoscopes

12817Ophthalmoscopes,Direct

12818Ophthalmoscopes,Indirect

12820Ophthalmotropometers

12821Optometers

12822Optomyometers

UMDNS

CODE

UMDNS TERM English

12823Oral Administration Sets

12825Orange Sticks

12826Organ Preservation Systems

12830Cement,Orthopedic

12833Orthopedic Internal Fixation Systems,Fracture 12837Orthoses

12839Oscilloscopes

12841Oscillotonometers

12842Osmometers

12844Osteotomes

12845Osteotomes,Orthopedic

12846Osteotomes,Plastic Surgery

12847Ostomy Appliances

12849Otoscopes

12853Oximeters

12855Oxygen Administration Kits

12858Oxygen Analyzers

12861Oxygen Analyzers,Continuous Controlling 12863Oxygen Monitors

12868Oxygen Canisters

12873Oxygen Concentrators

12875Tubing,Oxygen Connecting

12876Oxygen-Air Proportioners

12879Alarms,Oxygen Depletion

12883Oxygen Generators

12893Tents,Oxygen

12899Ozone Generators

12900Leads,Pacemaker,Implantable Endocardial 12911Pacemakers,Cardiac

12912Pacemakers,Cardiac,External Invasive 12913Pacemakers,Cardiac,Implantable

12928Pressure Pads,Alternating

12934Medicated Pads

12935Percussion Pads

12936Pressure Pads

12940Pressure Pads,Air

12941Pressure Pads,Animal Skin

12942Pressure Pads,Foam

12943Pressure Pads,Foam Convoluted

12944Pressure Pads,Gel

12945Pressure Pads,Mud

12946Pressure Pads,Water Cushion

12950Pain Gauges,Cutaneous

12955Papanicolaou Smear Kits

12956Baths,Paraffin,Physical Therapy

12957Parallel Bars

12962Parturiometers

12963Cabinets,Pass-Through

12971Patient Utensil Kits

12980Pelvimeters

12981Pelviscopes

12984Penetrometers

12986Percussors

12989Perforators

12990Perforators,Amniotic Membrane

12991Perforators,Ear Lobe

12993Perimeters

12996Irrigation Kits,Perineal

12998Peripheral Vision Analyzers

13003Peritoneoscopes

13004Pessaries

13005Pessaries,Diaphragm

13006Phaneroscopes

13008Phantoms UMDNS

CODE

UMDNS TERM English

13009Phantoms,Radiographic

13010Phantoms,Ultrasound

13011Pharyngoscopes

13012Phlebographs

13017Phonocardiographs

13018Phonocatheters

13020Phonostethographs

13022Photocatheters

13026Photofluorometers

13027Photofluoroscopes

13031Light Meters,Photomicrographic 13037Phototherapy Units

13039Picks,Middle Ear

13041Cutters,Pin and Wire

13043Pinwheels

13049Plates

13050Plates,Bone

13052Plates,Cranioplasty

13055Pledgets

13056Plethysmographs

13059Plethysmographs,Body

13069Pneumatic Counterpressure Suits 13074Pneumatic Testers

13078Pneumographs

13080Pneumotachographs

13081Pneumothorax Units

13085Polygraphs

13088Baths,Portable

13090Charts,Posture

13097Prep Kits

13100Pressure Infusors

13102Pressure Measuring Units

13106Sphygmomanometers

13107Manometer Sets,Cerebrospinal Fluid 13108Pressure Measuring Units,Esophageal 13109Pressure Measuring Units,Inspiratory 13110Pressure Measuring Units,Intracranial 13114Calibrators,Pressure Transducer 13116Covers,Thermometer,Electronic Probe 13117Probes

13118Probes,Common Duct

13119Probes,Eye

13120Probes,Eye,Lacrimal

13121Probes,Fistula

13124Probes,Sinus

13125Probes,Thermometer

13126Proctoscopes

13127Proctosigmoidoscopes

13129Prophylaxis Kits,Dental

13131Prostheses

13134Prostheses,Arm

13135Prostheses,Bile Duct

13136Prostheses,Bladder Support

13138Prostheses,Cardiac Valve

13139Prostheses,Cerclage,Cervix

13140Prostheses,Chin

13143Prostheses,Ear

13145Prostheses,Esophageal

13146Spheres,Eye

13148Prostheses,Fallopian Tube

13150Prostheses,Foot

13151Prostheses,Hand

13152Prostheses,Heart

13158Prostheses,Joint

UMDNS

CODE

UMDNS TERM English

13159Prostheses,Larynx

13160Prostheses,Leg

13161Prostheses,Mammary

13162Prostheses,Maxillofacial

13164Prostheses,Muscle

13165Patches,Myocardial

13167Prostheses,Penile

13168Prostheses,Joint,Wrist

13171Prostheses,Tendon

13172Prostheses,Testicle

13174Prostheses,Tracheobronchial

13175Prostheses,Urethral

13176Prostheses,Urethral Sphincter

13177Prostheses,Blood Vessel,Artificial

13180Prosthesis Implantation Instruments,

Orthopedic

13182Pulmonary Function Analyzers,Adult 13187Testers,Pulp

13188Pulsatile Pressure Generators

13192Pumps

13201Pumps,Dye Dilution

13203Pumps,Extracorporeal Perfusion

13209Pumps,Enteral Feeding

13215Infusion Pumps,General-Purpose

13217Infusion Pumps,Syringe

13220Infusion-Withdrawal Pumps

13224Pumps,Obstetrical Decompression

13228Punches

13229Punches,Aortic

13230Punches,Biopsy

13231Punches,Bone

13232Punches,Corneoscleral

13233Punches,Dermal

13234Punches,Hair Transplant

13235Pupillographs

13236Pupillometers

13237Pyeloscopes

13239Pyrometers

13241Pyroscopes

13248Warmers,Radiant

13249Warmers,Radiant,Adult

13250Warmers,Radiant,Infant

13251Warmers,Radiant,Infant,Transport 13252Radiation Counters

13259X-ray Film Duplicators

13260Positioning Aids,

Radiographic/Radiotherapeutic

13267Radiographic Units

13269Radiographic Units,Dental

13271Radiographic Units,General-Purpose 13272Radiographic Units,Mobile

13274Recorders,Video Tape

13275Calibrators,Radioisotope

13276Radioisotope Transfer Units

13278Radiometers,Phototherapy

13279Radiotherapy Units

13280Simulators,Radiotherapy

13281Computers,Radiotherapy Planning System 13287Raspatories

13288Rasps

13289Rasps,Middle Ear

13290Rasps,Nasal

13291Rasps,Plastic Surgery

13297Reamers,Orthopedic UMDNS

CODE

UMDNS TERM English

13299Testers,Power,Receptacle,Electrical 13300Testers,Power,Receptacle,Mechanical 13313Refractors,Ophthalmologic

13314Alarms,Refrigerator

13315Refrigerators

13316Refrigerators,Morgue

13317Regional Perfusion Units

13318Heat Exchangers,Regional Perfusion 13319Oxygenators,Regional Perfusion 13320Regulators

13323Regulators,High-Pressure Gas

13325Regulators,Suction

13329Regulators,Suction,Low-Volume 13332Regulators,Suction,Thoracic

13333Regulators,Suction,Tracheal

13335Resectoscopes

13338Reservoirs,Cardiotomy

13340Testers,Resistance,Line Cord

13341Simulators,Respiration

13346Restraints

13347Restraints,Ankle

13348Restraints,Arm

13349Restraints,Body

13351Restraints,Crib

13355Restraints,Vest

13356Restraints,Wheelchair Occupant

13357Restraints,Wrist

13360Resuscitators

13361Resuscitators,Cardiac

13363Resuscitators,Cardiopulmonary

13364Resuscitators,Pulmonary

13366Resuscitators,Pulmonary,Gas-Powered 13367Resuscitators,Pulmonary,Manual 13368Retainers

13369Retainers,Bandage

13370Retainers,Orthodontic

13371Retainers,Visceral

13372Retinoscopes

13373Retractors

13375Retractors,Abdominal

13376Retractors,Bladder

13377Retractors,Brain

13378Retractors,Brain Decompression 13379Retractors,Cardiac

13380Retractors,Dental

13381Retractors,Eye

13383Retractors,Hand Operating

13384Retractors,Laminectomy

13385Retractors,Orbital

13386Retractors,Orthopedic

13387Retractors,Plastic Surgery

13388Retractors,Rectal

13389Retractors,Rib

13390Retractors,Self-Retaining Operating 13391Retractors,Thoracic

13392Retractors,Vaginal

13393Retractors,Vessel

13395Rhinoanemometers

13396Rhinoscopes

13399Cutters,Ring

13403Dental Casting Rings

13414Cotton Rolls

13416Rongeurs

13418Rongeurs,Neurosurgical

UMDNS

CODE

UMDNS TERM English

13419Rongeurs,Rib

13425Routers,Bone Cutting

13426Rowing Units

13427Rubber Dams

13432Safes,Isotope

13439Sand Bags

13441Sanitary Belts

13443Sanitary Pads

13444Sanitizers

13447Blades,Saw

13448Saws

13449Saws,Bone

13450Saws,Bone,Electrical

13451Saws,Bone,Manual

13452Saws,Bone,Pneumatic

13454Scalers

13455Scales

13457Scales,Autopsy

13458Scales,Bed

13459Scales,Blood

13460Scales,Chair

13461Scales,Floor

13462Scales,Infant

13463Scales,Sponge

13468Scanners

13469Scanners,Computed Tomography 13472Scarifiers

13480Scissors

13481Scissors,Bandage

13482Scissors,Cardiovascular

13484Scissors,Endoscopic

13485Scissors,Eye

13486Scissors,Eye,Corneal

13487Scissors,Eye,Enucleation

13488Scissors,Eye,Iris

13489Scissors,Eye,Suture

13490Scissors,Eye,Tenotomy

13492Scissors,Dissecting

13493Scissors,Gynecological

13495Scissors,Nasal

13496Scissors,Neurosurgical

13498Scissors,Orthopedic

13499Scissors,Pediatric

13500Scissors,Plastic Surgery

13501Scissors,Rectal

13502Scissors,Suture

13504Scissors,Thoracic

13507Sclerotomes

13508Scoops

13509Scoops,Gallstone

13512Scrapers,Cytology

13513Screens

13514Screens,Bedside

13517Screwdrivers,Bone

13520Scrub Dresses

13522Scrub Dresses,Disposable 13523Scrub Dresses,Reusable

13524Scrub Suits

13526Scrub Suits,Disposable

13527Scrub Suits,Reusable

13529Binders,Scultetus

13532Searchers,Mastoid

13536Sensors

13538Sensors,Oxygen UMDNS

CODE

UMDNS TERM English

13540Separators

13542Separators,Dural

13543Separators,Pylorus

13544Separators,Toe

13549Sharpeners

13550Sharpeners,Dental

13551Sharpeners,Knife

13552Sharpeners,Needle

13561Sheets

13563Shields

13564Shields,Breast

13565Shields,Bunion

13569Shields,Syringe,Radiation

13570Shields,Wound

13574Covers,Shoe

13575Covers,Shoe,Conductive

13576Shoes

13578Shoes,Conductive

13579Shoes,Corrective

13583Shroud Kits

13584Shunt Adapters

13585Shunts

13586Shunts,Arteriovenous

13589Shunts,Peritoneovenous

13594Sigmoidoscopes

13598Silicone Rubber Sheeting

13607Chairs,Sitz Bath

13608Sitz Bath Kits

13609Baths,Sitz

13613Skin Graft Cutters

13614Skin Graft Cutters,Expanded Mesh 13620Sleeves,Topical Oxygen Therapy 13621Slings

13622Slings,Arm

13623Slings,Knee

13624Slings,Leg

13625Slippers

13629Snake Bite Kits

13630Snares

13631Snares,Polyp

13632Snares,Tonsil

13633Socks

13634Socks,Fracture

13635Socks,Stump

13637Bowls,Solution

13642Sounds

13643Sounds,Urethral

13644Sounds,Uterine

13645Spatulas

13646Spatulas,Brain

13647Spatulas,Cement

13648Spatulas,Eye

13649Spatulas,Lung

13650Spatulas,Microsurgical

13651Spatulas,Middle Ear

13655Specimen Containers

13659Specimen Cutters

13662Specula,Ear

13663Specula,Eye

13664Specula,Nasal

13665Specula,Rectal

13666Specula,Vaginal

13668Speech Therapy Units

13670Sphygmocardiographs

UMDNS

CODE

UMDNS TERM English

13671Sphygmographs

13673Spine Boards

13674Spirometers

13679Spirometers,Monitoring

13680Spirometers,Diagnostic

13681Splints

13683Splints,Molded

13684Splints,Molded,Aluminum

13685Splints,Molded,Plastic

13686Splints,Padded Stays

13687Splints,Pneumatic

13688Splints,Traction

13689Splints,Vacuum

13690Splints,Wire Board

13691Basins,Sponge

13692Bowls,Sponge

13693Counters,Sponge

13695Sponges

13698Sponges,Dissector

13699Sponges,Filmated

13700Sponges,Gauze

13701Sponges,Germicidal

13702Sponges,Neuro

13703Sponges,Rayon Cellulose

13704Sponges,Ophthalmic

13705Sponges,X-ray Detectable

13706Spreader Bars

13707Spreaders

13708Spreaders,Plaster

13709Spreaders,Rib

13710Spreaders,Vein

13725Baths,Steam

13727Stereotactic Headframes

13730Sterilization Containers

13731Sterilization Process Indicators

13732Sterilization Process Indicators,Biological 13734Sterilization Process Indicators,Chemical 13735Sterilization Packaging

13737Sterilizing Units

13739Sterilizing Units,Dry Heat

13740Sterilizing Units,Ethylene Oxide

13741Germicides,Liquid,Formaldehyde

13745Sterilizing Units,Radiation

13746Sterilizing Units,Steam

13748Sterilizing Units,Vapor

13750Stethoscopes

13754Stethoscopes,Electronic

13755Stethoscopes,Mechanical

13756Stethoscopes,Ultrasonic

13762Stimulators

13763Stimulators,Acupuncture

13764Stimulators,Auditory

13765Stimulators,Aversion Conditioning

13768Stimulators,Carotid Sinus Nerve

13770Stimulators,Interdental

13775Stimulators,Neuromuscular

13780Stimulators,Tactile

13782Stimulators,Electroanalgesic,Transcutaneous Electrical Nerve

13783Stimulators,Visual

13785Stockinettes

13789Stockings,Compression

13793Stockings,Pneumatic

13796Covers,Stool UMDNS

CODE

UMDNS TERM English

13803Stopcocks

13805Strain Detectors

13806Strain Gauges

13809Straps

13810Straps,Clavicle

13812Straps,Retaining

13814Stretchers

13816Stretchers,Mobile

13818Stretchers,Portable

13820Stretchers,Transfer

13822String,Gastrointestinal

13823Strippers

13824Strippers,Artery

13825Strippers,Donor Tube

13826Strippers,Drain Tube

13827Strippers,Tendon

13828Strippers,Vein

13833Stylets

13834Stylets,Bronchial

13835Stylets,Intravenous

13836Stylets,Needle

13837Stylets,Peritoneal

13839Stylets,Urethral

13845Suction Irrigators

13846Suction Kits

13848Suction Tips

13858Supports

13861Supports,Arch

13862Supports,Arm

13873Supports,Scrotal

13880Testers,Surgical Glove

13882Surgical Head Coverings

13886Surgical Packings

13887Surgical Packs

13890Suture Bolsters

13891Suture Buttons

13892Suture Kits

13894Suture Removal Kits

13895Suture Rings

13896Sutures

13898Sutures,Catgut

13899Sutures,Collagen

13900Sutures,Cotton

13902Sutures,Linen

13904Sutures,Stainless Steel Multifilament 13905Sutures,Nylon

13906Sutures,Polyester

13907Sutures,Polyethylene

13908Sutures,Polyglycolic Acid

13909Sutures,Polypropylene Monofilament 13910Sutures,Silk

13911Sutures,Stainless Steel

13912Swabs

13913Applicators,Antiseptic,Swab

13914Swabs,Specimen Collecting

13922Syringe/Needle Adapters

13923Cutters,Syringe and Needle

13924Cleaners,Syringe

13925Crushers,Syringe and Needle 13929Syringes

13931Syringes,Anesthesia

13936Syringes,Catheter

13938Dental Syringes

13940Syringes,Hypodermic

UMDNS

CODE

UMDNS TERM English

13941Syringes,Insulin

13942Syringes,Irrigating

13945Syringes,Tuberculin

13946Binders,T

13949Tables

13951Tables,Anesthetist's

13953Tables,Autopsy

13956Tables,Blood Donor

13958Tables,Examination/Treatment

13959Tables,Instrument

13960Tables,Obstetrical

13961Tables,Operating

13962Tables,Orthopedic

13963Tables,Overbed

13964Tables,Physical Therapy

13967Tables,Traction

13969Tables,Urological

13970Tachistoscopes

13976Tanks,Full-Body

13979Tapes

13981Tapes,Cotton

13983Tapes,Umbilical

13987Physiologic Monitoring Systems,Telemetric 13988ECG Monitors,Telemetric

13990Temperature Monitors,Telemetric

13994Controllers,Temperature

13996Tenaculums

13997Tenaculums,Thyroid

13998Tenaculums,Uterine

13999Tenotomes

14002Tents

14007Test Drums

14020Thermographic Devices

14022Thermographic Devices,Infrared

14023Thermographic Devices,Liquid-Crystal 14024Thermometer Holders

14025Thermometer Kits

14027Shakers,Thermometer

14028Thermometers

14032Thermometers,Electronic

14034Thermometers,Electronic,Continuous 14035Thermometers,Electronic,Intermittent 14036Thermometers,Infrared

14038Thermometers,Mercury

14047Thoracoscopes

14051Thrombometers

14053Timers

14055Timers,Radiographic/Fluoroscopic

14056Tinnitus Therapy Units

14059Radiographic Units,Tomographic

14062Tongs

14063Tongs,Bone

14064Tongs,Skull

14066Tongue Depressors

14067Tonographs

14068Tonometers

14069Tonoscopes

14070Tonsillectomes

14071Toothbrushes

14072Tourniquets

14074Tourniquets,Pneumatic

14075Tourniquets,Cardiovascular

14077Towels,Surgical

14080Tracheal Tube Adapters UMDNS

CODE

UMDNS TERM English

14081Tracheal Tube Cuff Inflators 14082Cuffs,Tracheal Tube

14084Stylets,Tracheal Tube

14085Tubes,Tracheal

14089Cannulae,Tracheostomy

14090Tracheostomy Care Kits

14092Tracheostomy Tube Adapters 14093Tracheostomy Buttons

14094Cuffs,Tracheostomy Tube

14096Tubes,Tracheostomy

14099Tracheotomy Kits

14100Belts,Traction

14101Frames,Traction

14105Traction Units

14106Traction Units,Intermittent

14108Traction Units,Intermittent,Mobile 14109Traction Units,Static,Other 14110Traction Units,Static,Bed

14111Traction Units,Static,Chair 14113Trainers,Auditory

14115Transducers

14117Transducers,Flow

14118Transducers,Force

14119Transducers,Pressure

14121Transducers,Ultrasonic

14126Transfusion Kits

14128Recorders,Transient

14130Transilluminators

14141Treadmills

14144Tremographs

14146Trephines

14147Trephines,Bone

14148Trephines,Corneal

14149Trephines,Kidney

14150Trephines,Liver

14151Trephines,Lung

14152Trephines,Skull

14154Trocars

14155Trocars,Abdominal

14156Trocars,Amniotic

14157Trocars,Antrum

14158Trocars,Cardiovascular

14159Trocars,Gallbladder

14160Trocars,Laryngeal

14161Trocars,Thoracic

14162Trocars,Tracheal

14163Tropometers

14164Troposcopes

14168Trusses

14169Trusses,Hernia

14171Trusses,Infant

14172Trusses,Nasal

14174Clips,Fallopian Tube

14175Tubes

14182Tubes,Autoclaving

14183Tubes,Blood Collection

14187Tubes,Colon

14188Tubes,Connecting

14189Tubes,Culture

14190Tubes,Decompression

14191Tubes,Drainage

14194Tubes,Enema

14195Tubes,Esophageal

14196Tubes,Esophageal,Blakemore

UMDNS

CODE

UMDNS TERM English

14197Tubes,Esophageal,Replogle

14198Tubes,Esophageal,Sengstaken

14199Tubes,Feeding

14202Tubes,Gastrointestinal

14203Tubes,Gastrointestinal,Einhorn

14204Tubes,Gastrointestinal,Harris

14205Tubes,Gastrointestinal,Homer Smathers 14206Tubes,Gastrointestinal,Kaslow

14207Tubes,Gastrointestinal,Rehfus

14208Tubes,Gastrointestinal,Ryles

14209Tubes,Gastrointestinal Decompression,

Wangensteen

14210Tubes,Gastrointestinal Decompression 14211Tubes,Gastrointestinal Decompression,

Cantor

14212Tubes,Gastrointestinal Decompression,

Dennis

14213Tubes,Gastrointestinal Decompression,Miller-Abbott

14214Tubes,Gastrostomy

14215Tubes,Gastrostomy,Malecot

14216Tubes,Gastrostomy,Mushroom

14221Tubes,Nasogastric

14224Tubes,Nephrostomy

14225Tubes,Plasma Extractor

14226Tubes,Rebreathing

14227Tubes,Rectal

14230Tubes,Stomach Evacuator

14235Tubes,Transfer

14238Tubing

14239Tubing,Braided

14240Tubing,Conductive

14242Tubing,Flex

14243Tubing,Latex

14244Tubing,Nylon

14246Tubing,Polyethylene

14247Tubing,Polyvinyl Chloride

14252Tubing,Vinyl

14255Tuning Forks

14256Frames,Turning

14257Tweezers

14258Typoscopes

14262Detergents,Ultrasonic Cleaning System 14263Ultrasonic Cleaning Systems

14271Power Meters,Ultrasonic

14276Ultrasonic Unit Analyzers

14278Scanners,Ultrasonic

14285Ureterotomes

14286Bougies,Urethral

14287Urethrographs

14288Urethrometers

14289Urethroscopes

14290Covers,Urinal

14291Urinals

14292Urinary Catheterization/Collection Kits

14297Urinary Drainage Units

14298Urinary Collection Bags

14301Irrigation Kits,Urinary

14302Urine Strainers

14303Urine Specimen Containers

14307Urodynamic Measurement Systems

14308Uroflowmeters

14310Washers,Utensil

14313Uterine Packing Devices UMDNS

CODE

UMDNS TERM English

14317Vacuum Extractors,Obstetrical

14322Moulds,Vaginal

14323Vaginometers

14325Valves

14328Valves,Ear

14329Valves,Eye

14332Valves,Nonrebreathing

14337Valves,Positive End-Expiratory Pressure 14339Valvulotomes

14345Vectorcardiographs

14346Vein Finders

14351Pressure Alarms,Airway

14352Filters,Ventilator

14355Ventilators,Other

14359Ventilator IMV Controllers

14360Ventilators,Pressure-Cycled

14361Ventilators,Intensive Care,Neonatal/Pediatric 14364Ventriculoscopes

14367Depressors,Vessel

14369Vibrators

14371Vibrometers

14372Vibrophonocardiographs

14375View Boxes

14379Viscerotomes

14380Visual Field Plotters

14382Visual Function Analyzers

14384Visuometers

14386Vitrectomy Units

14389Voltmeters

14393Walkers

14410Ovens,Drying

14413Washer/Sterilizing Units

14421Waste-Disposal Units

14423Waste-Disposal Units,Sharps

14424Waste Receptacles

14426Waste Receptacles,Contaminated

14427Kick Buckets

14428Waste Receptacles,Radioactive

14429Water Bath Circulators

14434Water Purification Filters,Charcoal

14435Water Purification Systems,Deionization 14436Water Purification Filters,Particulate

14437Water Purification Systems,Reverse Osmosis 14438Water Purification Systems,Ultraviolet

14449Wheelchairs

14450Baths,Whirlpool

14455Wire Drivers

14457Wires,Ligature

14462Irrigation Kits,Wound

14464Wrappers,Sterile

14465Binders,Wrist

14467Xenon Systems

14472Diffractometers,X-ray

14473X-ray Film Cassette Holders

14474X-ray Film Cassettes

14475X-ray Film Dryers

14477X-ray Film Labelers

14480X-ray Film Processor Quality Control Monitors 14481X-ray Film,Sheet

14482X-ray Film,Dental

14486Screens,X-ray Film Cassette

14487Markers,X-ray

14490Shields,X-ray

14491Shields,X-ray,Apron

UMDNS

CODE

UMDNS TERM English

14493Shields,X-ray,Glove

14494Shields,X-ray,Gonadal

14498View Boxes,X-ray

15003Breathing Circuits,Ventilator

15010Air Detectors,Heart-Lung Bypass

15011Heart-Lung Bypass Unit Level Detectors 15012Heart-Lung Bypass Unit Tubing Sets 15013Cleaners

15014Analgesia Units

15015Oxygen Analyzers,Sampling

15016Aspirators,Emergency

15017Bottles,Endoscopic Wash

15018Brushes,Cytology

15019Calibrators,Anesthesia Unit

15020Calibrators,Respiratory Therapy Unit 15021Cannulae,Hemodialysis

15022Catheters,Hemodialysis

15023Catheters,Femoral

15024Chairs,Birthing

15025Clamps,Skull

15026Compresses,Cold

15027Computers,Stress Exercise

15028Cricothyrotomy Kits

15029Defibrillator/Monitors,Line-Powered 15030Flasks,Dewar

15031Hemodialysis Unit Single-Pass Converters 15032Transmitter/Receiver Systems,Telephone, EEG

15033Electrodes,Defibrillation

15034Embolization Prostheses,Intravascular 15035Filters,Steam

15036Gastrointestinal Motility Analyzers

15037Gowns,Isolation

15038Guillotines,Rib

15039Hemofiltration Units

15040Inserters,Contact Lens

15041Ligators,Umbilical

15042Manifolds,Gas

15043Manifolds,Liquid

15044Microscopes,Electron

15045Nebulizers,Nonheated

15046Oxygen Meters

15047Packers,Gauze

15048Pressure Reducers,Intraocular

15050Prostheses,Tracheal

15051Regulators,Suction,Surgical

15052Laparotomy Rings

15053Scales,Wheelchair

15054Separators,Stapes

15055Sheets,Drape

15056Covers,Shoe,Nonconductive

15057Sigmoidoscopes,Flexible

15058Sigmoidoscopes,Rigid

15059Simulators

15061Simulators,Temperature

15062Spectrometers,Mass

15063Splints,Molded,Other

15065Suture Units,Automatic

15066Swabs,Cotton

15067Synchronizers,Diagnostic Ultrasonic Unit 15068Synchronizers,Gamma Camera

15069Synchronizers,Radiographic Unit

15071Transducers,Pressure,Catheter Tip 15073Bronchoscopes,Flexible UMDNS

CODE

UMDNS TERM English

15074Bronchoscopes,Rigid

15075Laryngoscopes,Flexible

15076Laryngoscopes,Rigid

15078Aprons,Laboratory

15079Spectrophotometers,Atomic Absorption 15080Spectrophotometers,Fluorescence

15081Spectrophotometers,Infrared

15082Spectrophotometers,Ultraviolet

15083Spectrophotometers,UV/Visible

15084Spectrophotometers,Visible

15085Sponges,Laparotomy

15086Bottles,Sterile Solution

15087Stimulators,Bone Growth

15089Alcohol Analyzers

15090Amino Acid Analyzers

15091Antibiotic Susceptibility Analyzers

15092Blood Urea Nitrogen Analyzers

15093Carbon Monoxide Analyzers

15098Coagulation Analyzers,Automated

15100Electrolyte Analyzers

15101Enzyme Analyzers

15102Glucose Analyzers

15103Nitrogen Analyzers

15104Platelet Aggregation Analyzers

15105Heating Blocks

15106Baths,Freezing

15107Baths,Tissue Flotation

15108Baths,Water

15109Bilirubinometers

15110Blood Smear Makers

15111Burets

15112Counters,Cell

15113Cell Separators

15114Washers,Cell

15115Centrifuges,Blood Bank

15116Centrifuges,Floor

15117Centrifuges,Refrigerated

15118Chloridometers

15119Chromatography Columns

15120Chromatography Equipment,Column,Gas 15121Chromatography Equipment,Column,Liquid 15122Chromatography Equipment,Paper,Liquid 15123Chromatography Equipment,Thin-Layer, Liquid

15124Information Systems,Laboratory

15125Counters,Bacteria

15126Counters,Colony

15127Cryogenic Blood Banking Equipment

15128Iontophoresis Units,Sweat Test

15129Densitometers

15130Desiccators

15131Dialyzers,Serum/Urine

15132Counters,Cell,Differential

15133Diluters

15134Dispensers,Paraffin

15135Dispensers,Slide

15136Distilling Units

15137Electrodes,pH

15138Electrophoresis Equipment

15139Evaporators

15140Filter Papers

15141Fluorometers

15142Collectors,Fraction

15143Thyroid Function Units

UMDNS

CODE

UMDNS TERM English

15144Freezers,Blood Plasma

15145Freezers,Laboratory

15146Hemoglobinometers

15148Hoods,Microbiological

15149Immunodiffusion Equipment 15150Immunofluorescence Equipment 15151Incubators,Aerobic

15152Incubators,Anaerobic

15153Labware,Basic

15154Lifts,Mortuary

15155Loops,Inoculating

15156Microscopes,Laboratory,Light 15157Microtomes,Cryostat

15158Microtomes,Rotary

15159Microtomes,Sliding

15160Microtomes,Ultra

15161Mixers,Clinical Laboratory 15162Freezer Monitors

15163Nephelometers

15164pH Meters

15165Photometers

15166Pipettes

15167Extractors,Plasma

15168Pumps,Laboratory

15169Refractometers,Laboratory 15170Refrigerators,Biologic

15171Refrigerators,Blood Bank 15172Refrigerators,Explosion-Proof 15173Rotators

15174Saws,Autopsy

15175Scales,Laboratory

15177Sedimentation Rate Units 15178Shakers,Laboratory

15179Sharpeners,Microtome Knife 15180Sinks,Dissecting

15182Slide Stainers,Hematology 15183Slide Stainers,Histology

15184Counters,Scintillation

15185Slides,Microscope

15186Racks,Test Tube

15187Test Tubes

15188Tissue Culture Apparatus 15189Tissue Embedding Equipment 15190Tissue Processors

15191Titrators

15192Tubes,Capillary

15193Ultracentrifuges

15195View Boxes,Rh Typing

15196Washers,Labware

15197Washers,Pipette

15198Washers

15200Oximeters,Intracardiac

15201Oximeters,In Vitro

15202Anesthesia Kits,Other

15203Bandages,Other

15204Burs,Other

15205Cabinets,Other

15206Cannulae,Other

15207Cardiac Output Units,Other 15208Carts,Other

15209Catheters,Other

15210Chairs,Other

15211Chisels,Other

15212Clamps,Other UMDNS

CODE

UMDNS TERM English

15213Clips,Other

15214Cushions,Other

15215Dilators,Other

15216Dressings,Other

15217Electrodes,Other

15218Elevators,Other

15219Ergometers,Other

15220Exercisers,Other

15221Forceps,Other

15222Gloves,Other

15223Gowns,Other

15224Guides,Other

15225Hooks,Other

15226Knives,Other

15228Lights,Other

15229Mallets,Other

15230Masks,Other

15231Masks,Air-Oxygen,Other

15233Heart Rate Monitors,Other

15234Needles,Other

15235Osteotomes,Other

15236Perforators,Other

15237Probes,Other

15238Probes,Eye,Other

15239Punches,Other

15240Rasps,Other

15242Retractors,Other

15243Rongeurs,Other

15244Saws,Other

15245Scissors,Other

15246Scissors,Eye,Other

15247Snares,Other

15248Sounds,Other

15249Spatulas,Other

15250Specula,Other

15251Splints,Other

15252Sponges,Other

15253Spreaders,Other

15254Strippers,Other

15255Sutures,Other

15256Syringes,Other

15257Tables,Other

15258Tenaculums,Other

15259Trephines,Other

15260Trocars,Other

15261Tubes,Esophageal,Other

15262Tubes,Gastrointestinal,Other

15263Tubes,Gastrointestinal Decompression,Other 15264Tubes,Gastrostomy,Other

15265Tubing,Other

15266Shields,X-ray,Other

15267Phantoms,Nuclear Medicine

15268Filters,Radio-Frequency

15269Magnets,Eye

15270Drains,Sump

15271Transmitter/Receiver Systems,Telephone, ECG

15272Incubators,Test Tube,Portable

15273Incubators,Test Tube,Stationary

15274Amniocentesis Kits

15275Awls

15276Ampules

15277Tubing,Silicone

15278Tubes,Other

UMDNS

CODE

UMDNS TERM English

15279Laminar Air Flow Units,Fixed

15280Laminar Air Flow Units,Mobile

15281Sponges,Scrub

15283Filters,Syringe

15284Injectors,Contrast Media,Angiography 15285Injectors,Contrast Media,Lymphangiography 15286Syringes,Angiography

15287Screens,Anesthesia

15288Entoptoscopes

15289Nephroscopes,Flexible

15290Nephroscopes,Rigid

15292Pillows,Cervical

15293Domes,Pressure Transducer

15295Scanners,Long-Term Recording,ECG 15296Transducer Holders

15297Timers,Coagulation

15299Iron Analyzers

15300Lead Ion Analyzers

15301Radioimmunoassay Analyzers

15302Spectrometers,Nuclear Magnetic Resonance 15303Titrators,Calcium

15304Homogenizers,Tissue

15305Mixers,Blood Bank,Donor Blood

15306Microbiological Systems,Automated

15308Cables,Fiberoptic

15309Training Manikins,Cardiopulmonary

Resuscitation

15310Urinometers

15311Mounts,Monitor

15312Timers,Other

15313Culdocentesis Kits

15314Suction Tips,Electrosurgical

15315Tubes,Blood,Microcollection

15316Arthrogram Kits

15318Wound Drainage Kits,Closed,Craniotomy 15319Dressings,Skin Graft,Donor-Site

15320Catheter Flush Valves,Continuous

15321Gel,Ultrasonic Coupling

15322Tubes,Bronchial

15323Tubes,Myringotomy

15324Prostheses,Eustachian Tube

15325Vacuum Stabilized Pads

15326Exercisers,Wrist

15327Incubators,Test Tube

15550Alarms

15551Clinical Chemistry Analyzers

15552Coagulation Analyzers

15553Aprons

15554Basins

15555Baths

15556Belts

15557Binders

15558Blades

15559Bottles

15560Bougies

15561Bowls

15562Breathing Circuits

15563Calibrators

15564Catheterization Kits

15565Cement

15566Chambers

15567Charts

15568Chromatography Equipment

15569Clippers UMDNS

CODE

UMDNS TERM English

15571Covers

15572Cups

15573Cutters

15574Metal Detectors

15575Dialysate Delivery Systems

15576Droppers

15577Dynamometers

15578Electrodes

15579Electrodes,Electrosurgical

15580Extractors

15581Forensic Evidence Kits,Other

15582Frames

15583Freezers

15584Gel

15585Irrigation Kits

15586Jars

15587Manifolds

15588Microscopes,Laboratory

15589Microtomes

15590Mixers

15591Nephroscopes

15592Oxygenators

15593Pillows

15594Racks

15595Recorders

15596Sampling Kits

15597Scoops,Common Duct

15598Shakers

15599Slide Stainers

15600Spectrometers

15601Spectrophotometers

15602Specula

15604Synchronizers

15605Testers

15606Testers,Power,Receptacle

15607Traction Units,Static

15608Traps

15609Trays

15610Warmers

15611Water Purification Filters

15612Water Purification Systems

15613Ventilators

15614Nurse Call Systems

15615Vacuum Pumps,Central

15616Headwall Systems,Prefabricated

15617Patient Service Consoles

15618Tracks and Carriers

15619Tracks and Carriers,Cubicle Curtain

15620Tracks and Carriers,Intravenous

15621Microsurgical Instruments

15622Injectors,Uterine

15623Contact Lens Removers

15624Dressings,Tracheostomy Tube

15625Papillotomes

15627Spectrum Analyzers,Audio

15628Forceps,Grasping,Flexible Endoscopic 15629Retrieval Baskets,Biliary Stone

15630Vaginoscopes

15631Stimulator Analyzers,Transcutaneous Nerve 15632Tinnitus Masker Analyzers

15633Hearing Aid Analyzers

15634Middle Ear Analyzers

15635Retractors,Fiberoptic-Illuminated

15636Suction Tips,Fiberoptic-Illuminated

UMDNS

CODE

UMDNS TERM English

15638Lift Height Evaluation Units

15639Paper,Recording

15640Pressure Monitoring Tubing Sets

15642Immobilizers,Cervical

15643Drapes,Instrument

15645Humidifiers,Heat/Moisture Exchange 15646Drapes,Surgical,Disposable

15647Drapes,Surgical,Reusable

15648Timers,Apgar Scoring

15649Filters,Gas

15650Timers,Phototherapy

15651Stirrers

15652Loupes

15653Magnifiers,Operating

15654Forms,Medical and Patient

15656Scanners,Ultrasonic,Mammographic 15657Scanners,Ultrasonic,Obstetric/Gynecologic 15659Scanners,Ultrasonic,Other

15660Lights,Overbed

15661Sheets,Examination Table

15662Massage Machines,Physical Therapy 15663Pipetters

15664Controllers,Temperature,Humidifier 15665Controllers,Temperature,Other

15666Training Manikins

15667Training Manikins,Other

15668Tubing,Nonconductive

15669Rongeurs,Intervertebral Disk

15670Forceps,Bone

15671Clamps,Rectal

15672Forceps,Tonsil

15673Hooks,Rectal

15674Punches,Ear

15675Retractors,Mastoid

15676Snares,Nasal

15677Elevators,Uterine

15678Computers,Nuclear Medicine

15679Needles,Tine Test

15680Labware,Basic,Reusable

15681Labware,Basic,Disposable

15682Tubes,Centrifuge

15683Cuvettes,Spectrophotometer

15684Transmitter/Receiver Systems,Telephone, ECG,Single-Channel

15685Transmitter/Receiver Systems,Telephone, ECG,Multichannel

15686Laboratory Safety Equipment

15687Cover Glass,Microscope Slide

15688Filters,Shunt,Hydrocephalic

15689Applicators,Other

15690Chairs,Adjustable Height

15691Pressure Pads,Soft Rubber

15692Spuds,Eye,Electric

15693Patient Transfer Aids

15695Charts,Acupuncture

15697Eyewear,Safety

15698Cabinets,Microbiological

15699Covers,Heel Stirrup

15700Heel Stirrup Pads

15701Dishes,Petri

15702Crutch Tips,Rubber

15704Dressings,Occlusive

15705Sheets,Drape,Disposable

15706Sheets,Drape,Reusable UMDNS

CODE

UMDNS TERM English

15707Sheets,Operating Room,Disposable 15708Sheets,Operating Room,Reusable

15709Blood Gas/pH Analyzers

15710Forceps,Dental

15711Punches,Dental,Rubber Dam

15712Clamps,Dental,Rubber Dam

15713Rongeurs,Dental

15714Centrifuge Tube Adapters

15715Bibs,Obstetrical

15718X-ray Film Minifiers

15719EEG Monitors,Telemetric

15720EMG Monitors,Telemetric

15721EOG Monitors,Telemetric

15723Chairs,Examination/Treatment,Ophthalmic 15724Cabinets,Head/Neck Treatment

15726Stretchers,Radiographic

15731Phototherapy Units,Ultraviolet

15732Beds,Birthing

15733Scrub Machines,Surgical

15734Urologic Hangers

15735Catheter Tube Holders

15737Rhinomanometers

15738Sheets,Examination Table,Disposable 15739Sheets,Examination Table,Reusable 15740Eyeglasses,Aphakic

15741Rasps,Bone

15742Mailers

15743Mailers,Specimen Container,Insulated 15744Mailers,Specimen Container

15745Mailers,Slide

15747Speech Amplifiers

15748Cameras,Endoscopic

15749Covers,Bur Hole

15750Pill Crushers/Splitters

15751Shielding,Magnetic Field

15752Shields,Heat,Infant

15753Transmitter/Receiver Systems,Telephone, Physiologic Monitor

15754Cables/Leads,ECG

15756Aspirators,Ultrasonic

15757Lasers,Surgical

15759Microscope Contrast Enhancement Units 15760Beds,Electric,Obese

15762Lights,Ultraviolet,Other

15764Covers,Footswitch

15765Covers,Camera

15766Orthopedic Internal Fixation Systems,Spinal 15767Orthopedic External Fixation Systems,

Fracture

15768Cannulae,Aortic

15770Radiographic Quality Assurance Devices 15771Pacers,Counting,Cardiopulmonary

Resuscitation

15772Lubricants,Instrument

15774Blades,Cast Cutter

15775Drapes

15776Blood Potassium Monitors

15777Trays,Skin Scrub

15778Covers,Clamp

15779Cages,Animal

15780Timers,Radiotherapy Unit

15781Infusion Systems,Insulin,Closed-Loop 15783Ventilators,High-Frequency

15784Stents

UMDNS

CODE

UMDNS TERM English

15785Calibrators,Infusion Drop-Rate

15786Package Sealers

15787Sphincteroscopes

15788Ureteroscopes

15790Lumboscopes

15791Physiologic Monitoring Systems,Neonatal 15792Paging Systems,Other

15793Stretchers,Orthopedic

15794Scleral Buckling Devices

15795Cardiac Output Units,Radioisotope

15796Knives,Plasma

15797Laundry Bags,Infection Control

15798Trays,Food,Disposable

15799Trays,Food,Reusable

15800Forceps,Dissecting

15801Jaw Fracture Fixation Devices

15802Trays,Food

15803Laundry Bags,Other

15806Dressings,Periodontal

15808Containers,Evacuated

15809Bottles,Evacuated

15810Accelerometers

15811Anatomical Models

15812Cabinets,Drying

15813Cabinets,Formaldehyde

15814Cabinets,Laboratory

15815Cameras,Microscope

15816Training Arms,Intravenous

15817Isolated Power Systems

15818Cyclotrons

15819X-ray Film Cutters

15820Radioactive Sources

15821Contrast Media,Radiographic/Fluoroscopic 15822Silver Recovery Systems

15823Cameras,Multi-Image

15824Alarms,Central Gas System

15825Baths,Dialysate Warming

15826Diplopiometers

15827Dispensers,Soap

15828Racks,Drying

15829Extrication Devices

15830Floor Coatings,Conductive

15831Floor Mats

15832Flooring,Conductive

15833Ground Continuity Monitors

15834Grounding Devices,Antistatic

15835Grounding Systems

15836Covers,Hamper

15837Hamper Liners

15838Hamper Stands

15839Hampers

15840Paging Systems

15841Paging Systems,Public Address

15845Pantographs

15846Physician In/Out Registries

15847Plugs

15848Plugs,Explosion-Proof

15849Plugs,Ground

15850Plugs,Hospital Grade

15851Plugs,Locking

15852Rails

15853Rails,Bathtub

15854Rails,Commode

15855Rails,Wall UMDNS

CODE

UMDNS TERM English

15856Receptacles

15857Receptacles,Explosion-Proof

15858Receptacles,Ground

15859Receptacles,Hospital Grade

15860Receptacles,Locking

15861Television Sets,Hospital

15862Vials,Medication

15863Alarms,Voltage

15864Basins,Wash

15865Wound Moulages

15866Lights,Examination,Ceiling-Mounted 15867Brushes,Intramedullary

15868Needle Guides

15869Prostheses,Cardiac Valve,Artificial 15870Prostheses,Cardiac Valve,Biological 15871Shields,X-ray,Eye

15872Shields,X-ray,Portable

15873Sutures,Iodized

15874Diathermy Units,Ophthalmic

15875Prism Bars

15876Occluders,Ophthalmic

15877Probes,Microlaryngeal

15878Clamps,Carotid

15879Clamps,Coarctation

15881Clamps,Pediatric

15882Clamps,Vascular

15883Burs,Microsurgical

15884Irons,Brace Bending

15885Catheters,Dye Dilution

15886Carts,Central Supply

15887Carts,Food Service

15888Carts,Linen/Laundry

15889Carts,Service/Utility

15890Carts,Housekeeping

15891Carts,Surgical Case

15892Helium Analyzers

15893Acoustical Casewalls

15894Acoustical Rooms

15895Casework

15896Casework,General-Purpose

15897Casework,Laboratory

15898Casework,Modular

15899Casework,Nursing Station

15900Casework,Patient Room

15901Casework,Pharmacy

15903Medical Chart Holder Accessories 15904Compactors

15905Compactors,Fixed

15906Compactors,Portable

15907Corner Guards

15908Curtains,Shower

15909Curtains,Shower,Antibacterial 15910Curtains,Shower,Disposable

15911Curtains,Shower,Reusable

15912Dispensers,Ice

15913Freezers,Bone

15914Freezers,Eye Bank

15915Furniture,Patient Room

15916Laundry Equipment

15917Nourishment Stations

15918Radio-Frequency-Free Rooms 15920Refrigerators,Eye Bank

15921Refrigerators,Food,Reach-in

15922Refrigerators,Food,Walk-in

欧盟医疗器械分类规则

欧盟医疗器械的分类规则(93/42 EEC ) 第1条: 不接触病人或仅接触未受损皮肤类器械 规则的一般解释 本规则是所有无更具体规则规范的器械的后备规则。 此规则通常适用于那些仅与未受损皮肤接触或与病人无接触的器械。 Rule 1 Examples 除非适用于以下列出的其他规则,所有非侵入 式器械都属于I 类 -用于防止体液回流的收集设备(例如用于收集人体废物的尿液收集瓶(urine collection bottles),造瘘袋(ostomy pouches),大小便失禁垫(incontinence pads)或伤口引流 设备(collectors used with wound drainage devices))。这 些装置可能通过导管和管道与患者连接。 - 用于固定身体部位或对身体部位施压的装置(如有助于扭伤愈合的非灭菌敷料,熟石膏,颈椎项圈,重力牵引装置,压缩针织品等)(non-sterile dressings used to aid the healing of a sprain, plaster of Paris, cervical collars, gravity traction devices, compression hosiery) - 一般用于患者外部支持的设备(如病床(hospital beds),病人吊(patient hoists),助行器(walking aids),轮椅(wheelchairs),担架(stretchers),牙科病人椅(dental patient chairs) - 矫正用眼镜和镜框(corrective glassed and frames) - 诊断用听诊器(stethoscopes for diagnosis) - 眼部闭塞膏药(eye occlusion plasters) - Incision drapes - 导电胶(incision drapes) - 非侵入性电极(用于脑电图或心电图的电极) Non-invasive electrodes (electrodes for EEG Or ECG) - 图像增感屏(image intensifying screens) - 用于清除眼部杂物的永磁体(permanent magnets for removal of ocular debris) 分类的实际问题 一些以间接方式与人体接触的非侵入性器械,通过血液,其他体液或重新进入人体的液体的存储、输送、处理或通过能量传递到人体的的方式影响人体内部的生理过程。这些器械不在此规则的适用范围之内。因这类器械以间接方式对人体内产生危害,其分类受另外规则的规范。 S G S

欧洲有源医疗器械相关法规

COMMISSION REGULATION (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( 1 ), and in particular Article 9(10) thereof, Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 2 ), and in particular Article 11(14) thereof, Whereas: (1) For some medical devices the provision of instructions for use in electronic form instead of in paper form can be beneficial for professional users. It can reduce the environmental burden and improve the competitiveness of the medical devices industry by reducing costs, while maintaining or improving the level of safety. (2) Such possibility of providing instructions for use in elec - tronic form instead of in paper form should be limited to certain medical devices and accessories intended to be used in specific conditions. In any case, for reasons of safety and efficiency users should always have the possi -bility to obtain those instructions for use in paper form on request. (3) In order to reduce potential risks as far as possible, the appropriateness of the provision of instructions for use in electronic form should be subject to a specific risk assessment by the manufacturer. (4) In order to ensure that users have access to the instructions for use, appropriate information about access to those instructions for use in electronic form and about the right to request the instructions for use in paper form, should be provided. (5) To ensure unconditional access to the instructions for use in electronic form and to facilitate the communication of updates and of product alerts, the instructions for use in electronic form should also be available through a website. (6) Regardless of the language obligations imposed on manufacturers by the law of the Member States, manu -facturers who provide instructions for use in electronic form should indicate on their website in which Union languages those instructions are available. (7) Except for medical devices of Class I, as defined in Annex IX to Directive 93/42/EEC, the fulfilment of the obligations laid down in this Regulation should be reviewed by a notified body during the procedure applicable for conformity assessment based on a specific sampling method. (8) As the protection of the right to privacy of natural persons with respect to the processing of personal data should be ensured by manufacturers and notified bodies as well, it is appropriate to provide that websites containing instructions for use of a medical device fulfil the requirements of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data ( 3 ). (9) In order to ensure safety and consistency, instructions for use in electronic form which are provided in addition to complete instructions for use in paper form should be covered by this Regulation as regards limited requirements in relation to their contents and websites. (10) It is appropriate to provide for a deferred application of this Regulation so as to facilitate the smooth transition to the new system and to allow all operators and Member States time to adapt to it. (11) The measures provided for in this Regulation are in accordance with the opinion of the Committee set up by Article 6(2) of Directive 90/385/EEC, HAS ADOPTED THIS REGULATION: Article 1 This Regulation establishes the conditions under which the instructions for use of medical devices referred to in point 15 of Annex 1 to Directive 90/385/EEC and in point 13 of Annex I to Directive 93/42/EEC may be provided in electronic form instead of in paper form. It also establishes certain requirements concerning instructions for use in electronic form which are provided in addition to complete instructions for use in paper form relating to their contents and websites. Article 2 For the purposes of this Regulation, the following definitions shall apply: (a) ‘instructions for use’ means information provided by the manufacturer to inform the user of the device of its safe and proper use, of its expected performances and of any ( 1 ) OJ L 189, 20.7.1990, p. 17. ( 2 ) OJ L 169, 12.7.1993, p. 1. ( 3 ) OJ L 281, 23.11.1995, p. 31.

医疗器械进入欧盟医疗器械市场要求

入欧盟的相关知识 一、欧盟国家(共31 家) 1、2004 年5 月1 日前:法国、德国、意大利、荷兰、比利时、卢森堡、丹麦、爱尔兰、英国、希腊、西班牙、葡萄牙、奥地利、芬兰、瑞典; 2、2004 年5 月1 日加入:波兰、匈牙利、捷克、斯洛伐克、斯洛文尼亚、爱沙尼亚、拉脱维亚、立陶宛、塞浦路斯、马耳他; 3、欧洲自由贸易协会EFTA :挪威、列支敦士登、冰岛、瑞士; 4、新入欧盟:罗马利亚、保加利亚; 5、瑞士不要求产品携带CE 标志。 二、医疗器械CE 认证的通用要求 1、基本要求(总要求) (1 )安全性(任何风险与器械提供的益处相比较,必须在可以接受的范围内,故亦称风险分析); (2 )风险的可预防性或被消除性,至少应给予警告(报警系统或警戒报警系统); ( 3 )性能符合性(产品的基本要求); (4 )器械性能和安全的效期(器械的安全和性能必须在器械的使用寿命内得到保证。); (5 )器械的储存和运输(应保证器械在合理的运输、储存条件下不受影响)。 2、基本要求的具体包括如下14 条: (1 )器械设计和生产必须保证:按照其预定和条件使用,器械不会损害医疗环境、患者安全、操作者或其他人员的安全和健康;使用时的潜在危险与患者受益相比较可以为人们所接受,但应具有高水平的防护办法。 (2 )生产者的设计和制造方案,必须考虑在现有工艺技术条件下遵守安全准则、生产者应: 首先应尽可能降低甚至避免危险。 其次,对无法避免的危险采取适当的防护措施,包括安装报警装置;最后,告知用户所提供防护措施的弱点及其可能带来的危险。 ( 3 )器械必须取得生产者期望获得的功能。器械设计制造和包装应有利于第一条(2) (A)D 多规定的各项功能的发挥。 (4 )在生产线者确定的器械使用寿命期内,在正常使用可能出现的压力,第1、 2 、 3 款所指的各项性 能应保持稳定,不能危害医疗环境、危害患者、使用者或其他人员的健康。 (5 )器械的设计、生产和包装应当保证,器械的性能在运输和储存过程中只要遵守有关规定不会发生根本逆变。 (6)副作用的大小同器械的使用性能相比较可以为人们所接受。 (7 )化学、物理和生物性能 (8)感染和微生物污染。 (9)组装和环境因素 (10 )检测器械 (11 )辐射防护 (12 )带有能源或与其他能源相连接的器械

医疗器械标准大全

企业质量考核所需备案之各医疗器械标准 1.医用电气设备第一部分:安全通用要求-GB 9706.1-1995 2.医用电气设备第一部分:安全通用要求 1.并列标准:医用电气系统安全要求-GB 9706.15-1999 3.医用有机硅材料生物学评价试验方法-GB/T 16175-1996 4.医疗器械生物学评价第1部分:评价与试验-GB/T 16886.1-2001 5.编写和使用医用电气设备教材的导则-GB/Z 17994-1999 6.管理、医疗、护理人员安全使用医用电气设备导则-GB/T 17995-1999 7. 医疗保健产品灭菌生物指示物第1部分:通则-GB 18281.1-2000 8. 最终灭菌医疗器械的包装-GB/T 19633-2005 9. .医疗器械产品图样及设计文件的术语-YY/T 0047-91 10. 医疗器械产品工作图样的基本要求-YY/T 0048-91 1 1. 医疗器械产品图样及设计文件格式-YY/T 0049-91 12医疗器械产品图样及设计文件编号原则-YY/T 0050-91 13. 医疗器械产品图样及其主要设计文件的完整性-YY/T 0051-91 14. 医疗器械产品图样及设计文件的更改办法-YY/T 0052-91 15. 医疗仪器设备用产品铭牌-YY/T 0083-92 16. 质量体系医疗器械GB/T 19002-ISO 9002应用的专用要求-YY/T 0288-1996 17. 医疗器械风险管理对医疗器械的应用-YY/T 0316-2003 18. 医疗器械用于医疗器械标签、标记和提供信息的符号-YY 0466-2003 19. 医疗器械保障医疗器械安全和性能公认基本原则的标准选用指南-YY/T 0467-2003 20. 命名用于管理资料交流的医疗器械命名系统规范-YY/T 0468-2003

医疗器械进入欧盟医疗器械市场要求

入欧盟的相关知识 一、欧盟国家(共31家) 1、2004年5月1日前:法国、德国、意大利、荷兰、比利时、卢森堡、丹麦、爱尔兰、英国、希腊、 西班牙、葡萄牙、奥地利、芬兰、瑞典; 2、2004年5月1日加入:波兰、匈牙利、捷克、斯洛伐克、斯洛文尼亚、爱沙尼亚、拉脱维亚、立陶宛、塞浦路斯、马耳他; 3、欧洲自由贸易协会EFTA:挪威、列支敦士登、冰岛、瑞士; 4、新入欧盟:罗马利亚、保加利亚; 5、瑞士不要求产品携带CE标志。 二、医疗器械 CE认证的通用要求 1、基本要求(总要求) (1)安全性(任何风险与器械提供的益处相比较,必须在可以接受的范围内,故亦称风险分析); (2)风险的可预防性或被消除性,至少应给予警告(报警系统或警戒报警系统); (3)性能符合性(产品的基本要求); (4)器械性能和安全的效期(器械的安全和性能必须在器械的使用寿命内得到保证。); (5)器械的储存和运输(应保证器械在合理的运输、储存条件下不受影响)。 2、基本要求的具体包括如下14条: (1)器械设计和生产必须保证:按照其预定和条件使用,器械不会损害医疗环境、患者安全、操 作者或其他人员的安全和健康;使用时的潜在危险与患者受益相比较可以为人们所接受,但应具有高 水平的防护办法。 (2)生产者的设计和制造方案,必须考虑在现有工艺技术条件下遵守安全准则、生产 者应:首先应尽可能降低甚至避免危险。 其次,对无法避免的危险采取适当的防护措施,包括安装报警装 置;最后,告知用户所提供防护措施的弱点及其可能带来的危险。 (3)器械必须取得生产者期望获得的功能。器械设计制造和包装应有利于第一条(2) (A)D多规定的各项功能的发挥。 (4)在生产线者确定的器械使用寿命期内,在正常使用可能出现的压力,第1、2、3款所指的各项性能 应保持稳定,不能危害医疗环境、危害患者、使用者或其他人员的健康。 (5)器械的设计、生产和包装应当保证,器械的性能在运输和储存过程中只要遵守有关规定不会 发生根本逆变。 (6)副作用的大小同器械的使用性能相比较可以为人们所接受。 (7)化学、物理和生物性能 (8)感染和微生物污染。 (9)组装和环境因素 (10)检测器械 (11)辐射防护 (12)带有能源或与其他能源相连接的器械 (13)生产者提供的操作信息 (14)如果需要根据医疗数据确定器械是否满足基本要求,如第六款的情形,有关数据必须按照附录Ⅹ

医疗器械进入欧盟医疗器械市场要求

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医疗器械标志、标签要求.doc

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?YY0466-2003《医疗器械用于医疗器械标签、标记和提供信息的符号》 ?YY/T0313-1998《医用高分子制品包装、标志、运输和贮存》?GB9706.1-1995《医用电气设备第一部分:安全通用要求》 ?YY91099-1999《医用X线设备标志、包装、运输和贮存》 专用标准 ?YY0089-1992《病人监护系统专用安全要求》 ?YY0319-2000《医用电气设备第二部分:医疗诊断用磁共振设备安全专用要求》 ?GB9706.X-XXXX《医用电气设备第X部分:XX设备安全专用要求》 ?YY0290.4-1997《人工晶体第4部分:标签和资料》 ?YY/T0486-2004《激光手术专用气管插管标志和提供信息的要求》 产品标准 ?GB8369-2005《一次性使用输血器》 ?GB10152《B型超声诊断设备》 ?YY0460-2003《超声洁牙设备》 医用高分子制品标志 ?单包装或初包装宜有下列标志: —产品名称、型号或规格; —制造厂名称、地址和商标; —生产批号或日期。 ?无菌产品的单包装或初包装还宜有下列标志:

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医疗器械注册产品标准(完整样本模板)

医疗器械注册专员培训 YZB 标准名称 (企业单位名称)发布

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标准名称 1 范围 本标准规定了XXX产品的结构和基本参数、要求、试验方法、检验规则、标志、包装、运输、贮存。 本标准适用于XXX产品(以下简称XX)。该产品供医疗单位_____( 用途 )___________________。 2 规范性引用文件 下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本标准。 GB/T 191—2000 包装储运图示标本 GB 9706.1—1995 医用电器设备第一部分:安全通用要求 GB/T 14710—1993 医用电器设备环境要求及试验方法 3 结构和基本参数 3.1 结构:XXX产品由主机、控制部分、输出部分组成。

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欧盟医疗器械CE认证监管模式简介 一、欧盟简介 欧洲联盟(European Union),简称欧盟(EU),是由欧洲共同体(European Communities) 发展而来,是一个集政治实体和经济实体于一身、在世界上具有重要影响的区域一体化组织。1991年12月,欧洲共同体马斯特里赫特首脑会议通过《欧洲联盟条约》,通称《马斯特里赫特条约》(简称《马约》)。1993年11月1日,《马约》正式生效,欧盟正式诞生。欧盟的宗旨是―通过建立无内部边界的空间,加强经济、社会的协调发展和建立最终实行统一货币的经济货币联盟,促进成员国经济和社会的均衡发展‖,―通过实行共同外交和安全政策,在国际舞台上弘扬联盟的个性‖。目前欧盟有27个成员国(Member State),4个自由贸易区域(European Free Trade Area)。 欧盟的主要组织机构有: 欧洲理事会(European Council) ,即首脑会议,由欧盟成员国国家元首或政府首脑及欧盟委员会主席组成。是欧盟的最高权力机构。理事会下设有总秘书处。 欧盟委员会(Commission of European Union) ,是欧盟的常设执行机构。负责实施欧盟条约和欧盟理事会做出的决定,处理日常事务,代表欧盟对外联系和进行贸易等方面的谈判。 欧洲议会(European Parliament) ,是欧洲联盟的执行监督、咨询机构,在某些领域有立法职能,并有部分预算决定权。欧洲议会可以2/3多数弹劾欧盟委员会,迫其集体辞职。 二、医疗器械的相关法规文件 目前,欧盟已颁布实施的医疗器械指令有三个,包括: 1、有源植入医疗器械指令(EC-Directive 90/385/EEC)。该指令适用于心脏起搏器、可植入的胰岛素泵等有源植入医疗器械,于1993年1月1日生效,1995年1月1日强制实施。 2、医疗器械指令(EC-Directive 93/42/EEC)。该指令适用于除90/385 EEC指令和98/79 EEC指令规定以外的一般医疗器械,于1995年1月1日生效,并于1998年6月14日强制实施。 3、体外诊断医疗器械指令(EC-Directive 98/79/EEC)。该指令适用于血细胞计数器、妊娠检测装置等体外诊断用医疗器械,于1998年12月7日生效,2003年12月7日强制实施。 上述指令是欧盟范围内统一执行的医疗器械管理法规,其法律地位相当于中国的《医疗器械监督管理条例》和日本的药事法(The Pharmaceutical Affairs Law)。 三个医疗器械指令虽然颁布的时间不同,但相互关联。医疗器械指令(EC-Directive 93/42/EEC)是在有源植入医疗器械指令(EC-Directive 90/385/EEC)的基础上制订的,二者又同为体外诊断医疗器械指令(EC-Directive 98/79/EEC)的编写基础。三个指令的格式、内容、基本要求大致相同,并针对医疗器械的不同特点而规定了特殊条款。当新颁布的指令对已有指令的基本要求进行修改时,已有指令同时进行相应修订。 医疗器械指令(EC-Directive 93/42/EEC)由23项条款和12个附录组成,其主要内容为: 1、定义和范围(Definitions,scope) 2、上市与投入使用(Placing on the market and putting into service) 该条款中规定制造商需采取所有必要的措施,确保医疗器械在依照设计的目的安装、维护和使用时不会危及患者、使用者或相关人员的安全及健康。 3、基本要求(Essential requirements) 该条款中规定医疗器械必须符合指令附录Ⅰ中的基本要求。 4、医疗器械的自由流通和特殊用途的医疗器械(Free movement,devices intended for special purposes) 该条款中规定各成员国不能对符合指令规定的临床研究用器械、定制器械和带有CE标记的医疗器械产品设置流通障碍。同时规定定制器械、参展器械和临床研究用器械在使用时可无需带有CE标记。 5、可参考的标准(Reference to standards) 6、标准与技术法规委员会(Committee on Standards and Technical Regulations) 该条款规定依据83/189/EEC号指令第五条所设立的委员会应协助欧盟委员会工作。

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二、医疗器械产品注册费 国务院食品药品监督管理部门和省级食品药品监督管理部门依照法定职责,对第二类、第三类医疗器械产品首次注册、变更注册、延续注册申请以及第三类高风险医疗器械临床试验申请开展行政受理、质量管理体系核查、技术审评等注册工作,并按标准收取有关费用。具体收费标准如下: 医疗器械产品注册费标准 单位:万元 注:1.医疗器械产品注册收费按《医疗器械注册管理办法》、《体外诊断试剂注册管理办法》确定的注册单元计收。 2.《医疗器械注册管理办法》、《体外诊断试剂注册管理办法》中属于备案的登记事项变更申请,不收取变更注册申请费。 3.进口医疗器械产品首次注册收费标准在境内相应注册收费标准基础上加收境内外 检查交通费、住宿费和伙食费等差额。 4. 港、澳、台医疗器械产品注册收费标准按进口医疗器械产品注册收费标准执行。 5.医疗器械产品注册加急费收费标准另行制定。 —4 —

中国医疗器械产品标准

YZB 医疗器械注册产品标准 YZB/苏(常)XXXX-200X 标准名称 标准英文名称(进口产品) 200X-XX-XX 发布200X-XX-XX 实施 X X X X (企业)发布

前言 XXX(产品名称)目前尚无国家标准和行业标准,根据《医疗器械标准管理办法》,特制定本标准,作为企业生产、监督的依据。 本标准的编写符合GB/T1.1-2000、GB/T1.2-2002和《医疗器械注册产品标准编写规范》的有关要求。 本标准的附录X是规范性附录; 本标准的附录X是资料性附录。 本标准由XXXXXXXXX(企业名称)提出。 本标准由XXXXXXXXX(企业名称)负责起草。 本标准主要起草人:XXX、XXX。 本标准首次发布时间:200X年X月。

XXXXXXXXX(标准名称) 1 范围 本标准规定了XXXXX的分类和标识、要求、试验方法、标志、使用说明书、包装、运输、储存的要求。 本标准适用于XXXXX(以下简称XXX)。该产品用于XXXXXXXXXXXXXXXXXXXXXXXX。 2 规范性引用文件 下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本标准。 GB XXXX-XXXX XXXXXXX YY XXXX-XXXX XXXXXXX ISO XXXXX-X:XXXXX XXXXX 3 分类和标记 3.1 分类 (产品的组成、结构、型式,结构、型式可用图表示、规格尺寸可列表表示) 3.2 标记 (为符合标准要求的产品(系列)建立一个分类、型号、产品代码) 4 要求 4.1外观 4.2尺寸 4.3 物理(或机械)性能 如强度、硬度、弹性、耐热性、耐磨性等。 4.4 使用性能 4.5 化学性能 如还原物质(易氧化物)、金属离子、酸碱度、蒸发残渣、紫外吸光度、环氧乙烷残留量等。 4.6 生物性能 如无菌、热原、溶血、刺激、致敏等(按GB/T16886.1) 4.7 安全性能 GB 9706医用电气设备通用安全要求系列标准; GB/T16886医疗器械生物学评价系列标准; YY/T口腔材料生物学评价系列标准; 及其他安全要求。 4.8 其他方面的要求 5 试验方法 5.1 外观 5.2 尺寸

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前言 XXX产品是我公司开发的新产品。目前该产品尚无国家标准、行业标准,为规范产品的技术特性,确保产品的安全有效,特制订本注册产品标准,做为生产质量控制的依据。 XXX产品注册产品标准引用了GB191《包装储运图示标志》,GBT14710《医用电气设备环境要求及试验方法》,GB9706.1《医用电气设备第一部分:安全通用要求》等标准中的内容。本标准的安全要求全面贯彻了GB9706.1—1995。并将其列入本标准附录A(规范性附录)。 本标准的附录A是规范性附录 本注册标准由天津市XXXXXXX公司提出并负责起草。 本注册标准主要起草人:XXX。 本注册标准首次发布于200X年XX月。 本注册标准由天津市XXXX(企业名称)法定代表人批准,并对所规定的内容负责。

标准名称 1 范围 本标准规定了XXX产品的结构和基本参数、要求、试验方法、检验规则、标志、包装、运输、贮存。 本标准适用于XXX产品(以下简称XX)。该产品供医疗单位_____( 用途)___________________。 2 规范性引用文件 下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,其随后所有的修改单(不包括勘误的内容)或修订版均不适用于本标准,然而,鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注日期的引用文件,其最新版本适用于本标准。 GB/T 191—2000 包装储运图示标本 GB 9706.1—1995 医用电器设备第一部分:安全通用要求 GB/T 14710—1993 医用电器设备环境要求及试验方法 3 结构和基本参数 3.1 结构:XXX产品由主机、控制部分、输出部分组成。 3.2 XXX产品的型号为:XX-XX-XX XX-XX-XX (对符号的解释)设计序号(产品规格)(罗马字母) (对符号的解释)产品分类(英文字母) (对符号的解释)企业名称简称(以汉字拼音字头) 3.3 XXX产品的基本参数 3.3.1 3.3.2 4 要求 4.1 XXX产品的工作条件 a)温度:5℃—40℃ b)相对湿度:不大于80% c)电源电压:AC220V±22V d)频率:50Hz±1Hz 4.2 性能指标: 4.2.1 XXX产品工作时噪声不大于60dB(A) 4.2.2 牵引力设置范围: 4.2.3 牵引治疗时间: 4.2.4 预置指示力示值与实际作用力误差: 4.2.5 预置指示时间与实际有效时间误差不大于±5% 4.3 安全

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目次 目次 (1) 前言 (4) 1.范围 (4) 2.规范性引用文件 (4) 3.分类 (4) 3.1术语与定义................................................................................................................ 错误!未定义书签。 3.2管理分类 (4) 3.3命名与型号 (4) 3.4组成 (4) 4.要求 (4) 4.1产品说明要求 (4) 4.1.1可用性 (4) 4.1.2内容 (4) 4.1.3标识和标示 (5) 4.1.4功能性陈述 (6) 4.1.4.1功能概述 (6) 4.1.4.1.1远程会诊系统 (6) 4.1.4.1.2双向转诊系统............................................................................................ 错误!未定义书签。 4.1.4.1.3计费系统.................................................................................................... 错误!未定义书签。 4.1.4.1.4医疗资源共享系统.................................................................................... 错误!未定义书签。 4.1.4.1.5管理系统.................................................................................................... 错误!未定义书签。 4.1.4.2 产品的功能........................................................................................................... 错误!未定义书签。 4.1.4.3当有软件组件的选项和版本时,应指明。 (6) 4.1.4.4功能性限制 .................................................................................................... 错误!未定义书签。 4.1.4.5对未授权访问的预防措施 (6) 4.1.5可靠性陈述 (6) 4.1.6易用性陈述 (6) 4.1.7效率陈述 (7) 4.1.8维护性陈述 (7) 4.1.9可移植性陈述 (7) 4.2用户文档集要求 (7) 4.2.1完备性 (7) 4.2.2正确性 (8) 4.2.3一致性 (8) 4.2.4易理解性 (8)

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