2001/90/EC: Decision No 1/2000 of 12 December 2000 of the Joint Committee established under the Agreement on Mutual Recognition between the European Community and the United States of America related to amending the Sectoral Annexes on telecommunication equipment, electromagnetic compatibility, pharmaceutical GMPs and medical devices
Date: 2000-12-12
Institutions: EC–United States of America Joint Committee
Subjects: United States, agreement (EU), harmonisation of standards, mutual recognition principle, pharmaceutical industry, telecommunications

3.2.2001

EN

Official Journal of the European Communities

L 34/55

DECISION No 1/2000

of 12 December 2000

of the Joint Committee established under the Agreement on Mutual Recognition between the
European Community and the United States of America related to amending the Sectoral Annexes
on telecommunication equipment, electromagnetic compatibility, pharmaceutical GMPs and
medical devices

(2001/90/EC)

THE JOINT COMMITTEE,

Having regard to the Agreement on Mutual Recognition between the European Community and the United
States of America, and in particular Article 14 and 21 thereof,

Whereas:

(1)

(2)

The Agreement should be amended to reflect changes in their respective legislation.

Pursuant to Article 21(2) any Sectoral Annex may, through the Joint Committee, be amended in
writing by the Parties,

HAS DECIDED AS FOLLOWS:

1. Amendments to the Sectoral Annex for telecommunications equipment

The Sectoral Annex for telecommunication equipment is amended according to the following:

(a) In Section I, under the EC column, the entire text is deleted and is replaced with the following:

‘Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio
equipment and telecommunications terminal equipment and the mutual recognition of their confor-
mity’.

(b) In Section III, paragraph 2(c), ‘Directive 98/13/EC’ is deleted and replaced with ‘Directive 1999/5/EC’.

(c) In Section III, paragraph 2, the following subparagraphs are added:

‘(d) prescription of radio tests to be performed pursuant to Annexes III and IV to Directive 1999/5/EC;
(e) issuing of an opinion on a technical file pursuant to Annex IV to Directive 1999/5/EC.’

(d) In Appendix 1, ‘ACTE Approval Committee for Terminal Equipment’, ‘ADLNB Association of Desig-
nated Laboratories and Notified Bodies’ and ‘CTR Common Technical Regulations’ are deleted.

2. Amendments to the Sectoral Annex for electromagnetic compatibility (EMC)

In Section IV, under the ‘US’ column,

‘Federal Aviation Administration (FAA)’

is deleted.

3. Amendments to the Sectoral Annex for pharmaceutical good manufacturing practices (GMPs)

Article 1, paragraph 3 is deleted in its entirety and is replaced with the following text:

‘3.

Good Manufacturing Practices (GMPs)

In the United States, GMPs means the requirements found in the legislation, regulations and adminis-
trative provisions for methods to be used in, and the facilities or controls to be used for, the
manufacturing, processing, packing, and/or holding of a drug to assure that such drug meets the
requirements as to safety, and has the identity and strength, and meets the quality and purity
characteristics that it purports or is represented to possess.

In the EC, GMPs are the part of quality assurance which ensures that products are consistently produced
and controlled to a quality standard. GMPs include, therefore, the system whereby the manufacturer
receives the specifications of the products and/or process from the marketing authorisation/product
authorisation or license holder or applicant and ensures the product is made in compliance with its
specifications (qualified person certification).

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Because equivalence is the cornerstone of this Annex, the authorities of the Parties will maintain their
respective requirements and will carry out the inspections against their own requirements.’

4. Amendments to the Sectoral Annex for medical devices

The Sectoral Annex for medical devices is amended according to the following:

(a) Table 1 is deleted in its entirety and is replaced with the revised Table 1, annexed hereto.

(b) Table 2 is deleted in its entirety and is replaced with the revised Table 2, annexed hereto.

This Decision, done in duplicate, shall be signed by representatives of the Joint Committee who are
authorised to act on behalf of the Parties for purposes of amending the Agreement. This Decision shall be
effective from the date of the later of these signatures.

Done at Washington DC, 12 December 2000.

Done at Brussels, 21 November 2000.

On behalf of the United States of America

On behalf of the European Community

Charlene BARSHEFSKY

Pascal LAMY

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Official Journal of the European Communities

L 34/57

ANNEX

TABLE 1

Class I products requiring premarket evaluations in the United States, included in scope of product coverage at
beginning of transition period

DENTAL PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

872.4200

DENTAL HANDPIECES AND ACCESSORIES

EBW — CONTROLLER, FOOT, HANDPIECE AND CORD

EFB — HANDPIECE, AIR-POWERED, DENTAL

EFA — HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL

EGS — HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

EKX — HANDPIECE, DIRECT DRIVE, AC-POWERED

EKY — HANDPIECE, WATER-POWERED

872.6250

DENTAL CHAIR AND ACCESSORIES

KLC — CHAIR WITH A UNIT

872.6640

DENTAL OPERATIVE UNIT AND ACCESSORIES

DYN — MOUTHPIECE, SALIVA EJECTOR

EBR — UNIT, SUCTION OPERATORY

EHZ — EVACUATOR, ORAL CAVITY

EIA — UNIT, OPERATIVE DENTAL

872.6710

BOILING WATER STERILISER

ECG — STERILISER, BOILING WATER

1.1. GASTROENTEROLOGY / UROLOGY PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

876.5160

UROLOGICAL CLAMPS FOR MALES

FHA — CLAMP, PENILE

GENERAL AND PLASTIC SURGERY PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

878.4460

SURGEON'S GLOVES

KGO — SURGEON'S GLOVES

880.5090

LIQUID BANDAGE

KMF — BANDAGE, LIQUID

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GENERAL HOSPITAL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

880.5680

PEDIATRIC POSITION HOLDER

FRP — HOLDER, INFANT POSITION

880.6250

PATIENT EXAMINATION GLOVE

LZB — FINGER COT

FMC — GLOVE, PATIENT EXAMINATION

LYY — GLOVE, PATIENT EXAMINATION, LATEX

LZA — GLOVE, PATIENT EXAMINATION, POLY

LZC — GLOVE, PATIENT EXAMINATION, SPECIALITY

LYZ — GLOVE, PATIENT EXAMINATION, VINYL

880.6375

PATIENT LUBRICANT

KMJ — LUBRICANT, PATIENT

MMS — LUBRICANT, VAGINAL, PATIENT

880.6760

PROTECTIVE RESTRAINT

BRT — RESTRAINT, PATIENT, CONDUCTIVE

FMQ — RESTRAINT, PROTECTIVE

NEUROLOGY PANEL

SECTION No

882.1030

ATAXIAGRAPH

GWW — ATAXIAGRAPH

REGULATION NAME,
PRODUCT CODE — DEVICE NAME

882.1420

ELECROENCEPHALOGRAM (EEG) SIGNAL SPECTRUM ANALYSER

GWS — ANALYSER, SPECTRUM, ELECTROENCEPHALOGRAM SIGNAL

882.4060

VENTRICULAR CANNULA

HCD — CANNULA, VENTRICULAR

882.4545

SHUNT SYSTEM IMPLANTATION INSTRUMENT

GYK — INSTRUMENT, SHUNT SYSTEM IMPLANTATION

OBSTETRICS AND GYNECOLOGY PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

884.2980

THERMOGRAPHIC SYSTEM

LHQ — SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE)

884.2982

LIQUID CRYSTAL TELETHERMOGRAPHIC SYSTEM

LHM — SYSTEM, TELETHERMOGRAPHIC, LIQUID CRYSTAL

KYA — SYSTEM, TELETHERMOGRAPHIC, LIQUID CRYSTAL, NON-POWERED

(ADJUNCTIVE USE)

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OPHTHALMOLOGY PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

886.4070

POWERED CORNEAL BURR

HQS — BURR, CORNEAL, AC-POWERED

HOG — BURR, CORNEAL, BATTERY-POWERED

HRG — ENGINE, TREPHINE, ACCESSORIES, AC-POWERED

HRF — ENGINE, TREPHINE, ACCESSORIES, BATTERY-POWERED

HLD — ENGINE, TREPHINE, ACCESSORIES, GAS-POWERED

886.4300

INTRAOCULAR LENS GUIDE

KYB — LENS, GUIDE, INTRAOCULAR

886.4370

KERATOME

HNO — KERATOME, AC-POWERED

HMY — KERATOME, BATTERY-POWERED

ORTHOPAEDIC PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

888.1500

GONIOMETER

KQX — GONIOMETER, AC-POWERED

PHYSICAL MEDICINE PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

890.3850

MECHANICAL WHEELCHAIR

LBE — STROLLER, ADAPTIVE

IOR — WHEELCHAIR, MECHANICAL

890.5710

HOT OR COLD DISPOSABLE PACK

IMD — PACK, HOT OR COLD, DISPOSABLE

RADIOLOGY PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

892.1100

SCINTILLATION (GAMMA) CAMERA

IYX — CAMERA, SCINTILLATION (GAMMA)

892.1110

POSITRON CAMERA

IZC — CAMERA, POSITRON

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TABLE 2

Class II medical devices included in the scope of product coverage at beginning of transitional period

(United States of America to develop guidance documents identifying US requirements and EC to identify standards
needed to meet European Union requirements)

ANESTHESIOLOGY PANEL

SECTION No

868.5630

NEBULISER

REGULATION NAME
PRODUCT CODE — DEVICE NAME

CAF — NEBULISER (DIRECT PATIENT INTERFACE)

CARDIOVASCULAR PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

870.1120

BLOOD PRESSURE CUFF

DXQ — CUFF, BLOOD-PRESSURE

870.1130

NON-INVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM (except non-oscillometric)

DXN — SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

870.2300

CARDIAC MONITOR (INCLUDING CARDIOTACHOMETER AND RATE ALARM)

DRT — MONITOR, CARDIAC (INCLUDING CARDIOTACHOMETER AND RATE ALARM)

870.2330

ECHOCARDIOGRAPH

DXK — ECHOCARDIOGRAPH

870.2340

ELECROCARDIOGRAPH

DPS — ELECTROCARDIOGRAPH

MLC — MONITOR, ST SEGMENT (without alarm)

870.2350

ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR

DRW — ADAPTOR, LEAD SWITCHING, ELECTROCARDIOGRAPH

870.2360

ELEKTROCARDIOGRAPH ELECTRODE

DRX — ELECTRODE, ELECTROCARDIOGRAPH

870.2370

ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER

KRC — TESTER, ELECTRODE, SURFACE, ELECTROCARDIOGRAPHIC

870.2880

ULTRASONIC TRANSDUCER

JOP — TRANSDUCER, ULTRASONIC

DENTAL PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

872.3060

GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE

EJT — ALLOY, GOLD BASED, FOR CLINICAL USE

EJS — ALLOY, PRECIOUS METAL, FOR CLINICAL USE

872.3200

RESIN TOOTH BONDING AGENT

KLE — AGENT, TOOTH BONDING, RESIN

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SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

872.3275

DENTAL CEMENT

EMA — CEMENT, DENTAL

EMB — ZINC OXIDE EUGENOL

872.3660

IMPRESSION MATERIAL

ELW — MATERIAL, IMPRESSION

872.3690

TOOTH SHADE RESIN MATERIAL

EBF — MATERIAL, TOOTH SHADE, RESIN

872.3710

BASE METAL ALLOY

EJH — METAL, BASE

GASTROENTEROLOGY/UROLOGY PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

876.1075

GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT

KNW — INSTRUMENT, BIOPSY

FCF — INSTRUMENT, BIOPSY, MECHANICAL, GASTROINTESTINAL

FCK — INSTRUMENT, BIOPSY, SUCTION

FCI — PUNCH, BIOPSY

FCG — SET, BIOPSY NEEDLE AND NEEDLE, GASTRO-UROLOGY

#876.1500

ENDOSCOPE AND ACCESSORIES

FEB — ACCESSORIES, CLEANING FOR ENDOSCOPE

FER — ANOSCOPE, NON-POWERED

FDP — APPARATUS, PNEUMOPERITONEUM, AUTOMATIC

FDX — BRUSH, CYTOLOGY, FOR ENDOSCOPE

FGS — CARRIER, SPONGE, ENDOSCOPIC

FBN — CHOLEDOCHOSCOPE, FLEXIBLE OR RIGID

FDF — COLONOSCOPE, GASTRO-UROLOGY

FTJ — COLONOSCOPE, GENERAL AND PLASTIC SURGERY

FFZ — CORD, ELECTRIC, FOR ENDOSCOPE

FAJ — CYTOSCOPE, DIAGNOSTIC

FBO — CYSTOURETHROSCOPE

FDT — DUODEDOSCOPE, ESOPHAGO GASTRO

KOG — ENDOSCOPE AND/OR ACCESSORIES

GCP — ENDOSCOPE, AC-POWERED AND ACCESSORIES

GCS — ENDOSCOPE, BATTERY-POWERED AND ACCESSORIES

GCR — ENDOSCOPE, DIRECT VISION

GDB — ENDOSCOPE, FIBER OPTIC

GCQ — ENDOSCOPE, FLEXIBLE

GCO — ENDOSCOPE, MIRROR

GCN — ENDOSCOPE, PRISM

GCM — ENDOSCOPE, RIGID

FDA — ENTEROSCOPE

GCL — ESOPHAGOSCOPE, GENERAL AND PLASTIC SURGERY

FDW — ESOPHAGOSCOPE, RIGID, GASTRO-UROLOGY

FDS — GASTROSCOPE, GASTRO-UROLOGY

GCK — GASTROSCOPE, GENERAL AND PLASTIC SURGERY

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SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

FFS — ILLUMINATOR, FIBEROPTIC, FOR ENDOSCOPE

FCX — INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

FHX — JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT

FTI — LAMP, ENDOSCOPE, INCANDESCENT

GCI — LARYNGOSCOPE

GCT — LIGHT SOURCE, ENDOSCOPIC, XENON ARC

FCW — LIGHT SOURCE, FIBEROPTIC, ROUTINE

FCQ — LIGHT SOURCE, INCONDESCENT, DIAGNOSTIC

FCR — LIGHT SOURCE, PHOTOGRAPHIC, FIBEROPTIC

GCH — MEDIASTINOSCOPE

FBK — NEEDLE, ENDOSCOPIC

FHP — NEEDLE, PNEUMOPERITONEUM, SIMPLE

FHO — NEEDLE, PNEUMOPERITONEUM, SPRING LOADED

FEC — OBTURATOR, FOR ENDOSCOPE

FTK — PANCREATOSCOPE, BILIARY

FAK — PANENDOSCOPE (GASTRODUODENOSCOPE)

FAL — PANENDOSCOPE (URETHROSCOPE)

GCG — PERITONEOSCOPE

GCF — PROCTOSCOPE

FEQ — PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

FJL — RESECTOSCOPE

FDC — RESECTOSCOPE, WORKING ELEMENT

FCC — RETRIEVER, ENDOMAGNETIC

FBI — RONGEUR, CYTOSCOPIC

KDO — RONGEUR, CYSTOSCOPIC, HOT

KGD — SCISSORS FOR CYTOSCOPE

FDE — SET, LAPAROSCOPY

FGA — SET, NEPHROSCOPE

FED — SHEATH, FOR ENDOSCOPE

FAM — SIGMOIDOSCOPE, FLEXIBLE

FAN — SIGMOIDOSCOPE, RIGID, ELECTRICAL

KDM — SIGMOIDOSCOPE, RIGID, NON-EECTRICAL

FDR — SPHYNCTEROSCOPE

FET — TAPE, TELEVISION AND VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC

FBP — TELESCOPE, RIGID, ENDOSCOPIC

GCW — TRANSFORMER, ENDOSCOPE

FGB — URETEROSCOPE

FGC — URETHROSCOPE

876.4500

MECHANICAL LITHOTRIPTER

LQC — LITHROTRIPTER, BILIARY MECHANICAL

FGK — TRIPSOR, STONE, BLADDER

876.5010

BILIARY CATHETER AND ACCESSORIES (biliary stone dislodger only)

LQR — DISLODGER, STONE, BILIARY

876.5320

NONIMPLANTED ELECTRICAL CONTINENCE DEVICE

KPI — STIMULATOR, ELECTRICAL FOR INCONTINENCE (NON-IMPLANTABLE)

876.5665

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

FIP — SUBSYSTEM, WATER PURIFICATION

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GENERAL HOSPITAL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

880.2910

CLINICAL ELECTRONIC THERMOMETER (except tympanic or pacifier)

FLL — THERMOMETER, ELECTRONIC, CLINICAL

880.5400

NEONATAL INCUBATOR

FMZ — INCUBATOR, NEONATAL

880.5410

NEONATAL TRANSPORT INCUBATOR

FPL — INCUBATOR, NEONATAL TRANSPORT

880.5570

HYPODERMIC SINGLE LUMEN NEEDLE

MMK — CONTAINER, SHARPS

FMI — NEEDLE, HYPODERMIC, SINGLE LUMEN (except anti-stick and self-destruct)

880.5725

INFUSION PUMP (external only)

MRZ — ACCESSORIES, PUMP, INFUSION

FRN — PUMP, INFUSION

LZF — PUMP, INFUSION, ANALYTICAL SAMPLING

MEB — PUMP, INFUSION, ELASTOMERIC

LZH — PUMP, INFUSION, ENTERAL

MHD — PUMP, INFUSION, GALLSTONE DISSOLUTION

MEA — PUMP, INFUSION, PCA

(except for combination products regulated under the InterCenter Agreement Between the Center
for Drug Evaluation and Research and the Center for Devices and Radiological Health, or the
InterCenter Agreement Between the Center for Biologics Evaluation and Research and the Center
for Devices and Radiological Health.)

880.5860

PISTON SYRINGE

FMF — SYRINGE, PISTON

880.6880

STEAM STERILISER (greater than 2 cubic feet (± 0,056m3)

FLE — STERILISER, STEAM

NEUROLOGY PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

882.1240

ECHOENCEPHALOGRAPH

GXW — ECHOENCEPHALOGRAPH

882.1320

CUTANEOUS ELECTRODE

GXY — ELECTRODE, CUTANEOUS

882.1400

ELECTROENCEPHALOGRAPH

GWQ — ELECTROENCEPHALOGRAPH

882.1480

NEUROLOGICAL ENDOSCOPE

GWG — ENDOSCOPE, NEUROLOGICAL

882.5890

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF

GZJ — STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

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OBSTETRICS AND GYNECOLOGY PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

884.1690

HYSTEROSCOPE AND ACCESSORIES

HIH — HYSTEROSCOPE (AND ACCESSORIES)

884.1720

GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES

HET — LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

884.2225

OBSTETRIC-GYNECOLOGIC ULTRASONIC IMAGER

HEN — CALIPER, FOETAL HEAD, ULTRASONIC

HHX — HOLOGRPAH, FOETAL ACOUSTICAL

HEM — IMAGER, ULTRASONIC OBSTETRIC-GYNECOLOGIC

HHJ — LOCATOR, INTRACORPOREAL DEVICE, ULTRASONIC

#884.2660

FOETAL ULTRASONIC MONITOR AND ACCESSORIES

HEP — MONITOR, BLOOD-FLOW, ULTRASONIC

HEL — MONITOR, HEART RATE, FOETAL, ULTRASONIC

HEK — MONITOR, HEART SOUND, FOETAL, ULTRASONIC

HEI — MONITOR, HEART-VALVE MOVEMENT, FOETAL, ULTRASONIC

HEJ — MONITOR, HEMIC SOUND, ULTRASONIC

HEQ — MONITOR, PRESSURE, ARTERIAL, FOETAL, ULTRASONIC

KNG — MONITOR, ULTRASONIC, FOETAL

884.2960

OBSTETRIC ULTRASONIC TRANSDUCER AND ACCESSORIES

HGL — TRANSDUCER, ULTRASONIC, OBSTETRIC

884.5300

CONDOM

HIS — CONDOM

OPHTHALMOLOGY PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

886.1570

OPHTHALMOSCOPE

HLI — OPHTHALMOSCOPE, AC-POWERED

HLJ — OPHTHALMOSCOPE, BATTERY-POWERED

886.1780

RETINOSCOPE

HKL — RETINOSCOPE, AC-POWERED

886.1850

AC-POWERED SLIT-LAMP BIOMICROSCOPE

HJO — BIOMICROSCOPE, SLIT-LAMP, AC-POWERED

886.4150

VITREOUS ASPIRATION AND CUTTING INSTRUMENT

MMC — DILATOR, EXPANSIVE, IRIS (ACCESSORY)

HQE — INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

HKP — INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED

MLZ — VITRECTOMY, INSTRUMENT CUTTER

886.4670

PHACOFRAGMENTATION SYSTEM

HQC — UNIT, PHACOFRAGMENTATION

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ORTHOPAEDIC PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

888.1100

ARTHROSCOPE

HRX — ARTHROSCOPE AND ACCESSORIES

RADIOLOGY PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

#884.2660

FOETAL ULTRASONIC MONITOR AND ACCESSORIES

LXE — DOPPLER, FOETAL ULTRASOUND

MAA — MONITOR, FOETAL DOPPLER ULTRASOUND

892.1000

MAGNETIC RESONANCE DIAGNOSTIC DEVICE

MOS — COIL, MAGNETIC RESONANCE, SPECIALITY

LNH — SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

LNI — SYSTEM, NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC

892.1200

EMISSION COMPUTED TOMOGRAPHY SYSTEM

KPS — SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

892.1310

NUCLEAR TOMOGRPAHY SYSTEM

JWM — SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

892.1360

RADIONUCLIDE DOSE CALIBRATOR

KPT — CALIBRATOR, DOSE, RADIONUCLIDE

892.1540

NONFOETAL ULTRASONIC MONITOR

JAF — MONITOR, ULTRASONIC, NONFOETAL

892.1550

ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

IYN — SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

892.1560

ULTRASONIC PULSED ECHO IMAGING SYSTEM

IYO — SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

892.1570

DIAGNOSTIC ULTRASONIC TRANSDUCER

ITX — TRANSDUCER, ULTRASONIC, DIAGNOSTIC

892.1600

ANGIOGRAPHIC X-RAY SYSTEM

IZI — SYSTEM, X-RAY, ANGIOGRPAHIC

892.1610

DIAGNOSTIC X-RAY BEAM LIMITING DEVICE

IZS — APERTURE, RADIOGRAPHIC

IZW — COLLIMATOR, AUTOMATIC, RADIOGRAPHIC

IZX — COLLIMATOR, MANUAL, RADIOGRAPHIC

IZT — CONE, RADIOGRAPHIC

KPW — DEVICE BEAM LIMITING, X-RAY, DIAGNOSTIC

892.1620

CINE OR SPOT FLUOROGRAPHIC X-RAY CAMERA

IZJ — CAMERA, X-RAY, FLUOROGRAPHIC, CINE OR SPOT

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SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

892.1630

ELECTROSTATIC X-RAY IMAGING SYSTEM

IXK — SYSTEM, IMAGING, X-RAY, ELECTROSTATIC

892.1650

IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM (except solid state)

JAA — SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

892.1670

SPOT FILM DEVICE

IXL — DEVICE, SPOT-FILM

892.1680

STATIONARY X-RAY SYSTEM

KPR — SYSTEM, X-RAY, STATIONARY

892.1720

MOBILE X-RAY SYSTEM

IZL — SYSTEM, X-RAY, MOBILE

892.1740

TOMOGRAPHIC X-RAY SYSTEM

IZF — SYSTEM, X-RAY, TOMOGRAPHIC

892.1750

COMPUTED TOMOGRAPHY X-RAY SYSTEM

JAK — SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

892.1820

PNEUMOENCEPHALOGRAPHIC CHAIR

HBK — CHAIR, PNEUMOENCEPHALOGRAPHIC

892.1850

RADIOGRAPHIC FILM CASSETTE

IXA — CASSETTE, RADIOGRAPHIC FILM

892.1860

RADIOGRAPHIC FILM/CASSETTE CHANGER

KPX — CHANGER, RADIOGRAPHIC FILM/CASSETTE

892.1870

RADIOGRAPHIC FILM/CASSETTE CHANGER PROGRAMMER

IZP — PROGRAMMER, CHANGER, FILM/CASSETTE, RADIOGRAPHIC

892.1900

AUTOMATIC RADIOGRAPHIC FILM PROCESSOR

EGT — CONTROLLER, TEMPERATURE, RADIOGRAPHIC

EGW — DRYER, FILM, RADIOGRAPHIC

IXX — PROCESSOR, CINE FILM

IXW — PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC

EGY — PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL

GENERAL AND PLASTIC SURGERY PANEL

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

#876.1500

ENDOSCOPE AND ACCESSORIES

GCJ — LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

878.4400

ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

HAM — APPARATUS, ELECTROSURGICAL

GEI — DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES

JOS — ELECTRODE, ELECTROSURGICAL

JOT — ELECTRODE, GEL, ELECTROSURGICAL

DWG —ELECTROSURGICAL DEVICE

BWA — UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES

3.2.2001

EN

Official Journal of the European Communities

L 34/67

SECTION No

REGULATION NAME
PRODUCT CODE — DEVICE NAME

878.4580

SURGICAL LAMP

HBI — ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD

FTF — ILLUMINATOR, NON-REMOTE

FTG — ILLUMINATOR, REMOTE

HJE — LAMP, FLUORESCEIN, AC-POWERED

FQP — LAMP, OPERATING-ROOM

FTD — LAMP, SURGICAL

GBC — LAMP, SURGICAL, INCANDESCENT

FTA — LIGHT, SURGICAL, ACCESSORIES

FSZ — LIGHT, SURGICAL, CARRIER

FSY — LIGHT, SURGICAL, CEILING MOUNTED

FSX — LIGHT, SURGICAL, CONNECTOR

FSW — LIGHT, SURGICAL, ENDOSCOPIC

FST — LIGHT, SURGICAL, FIBEROPTIC

FSS — LIGHT, SURGICAL, FLOOR STANDING

FSQ — LIGHT, SURGICAL, INSTRUMENT

878.4780

POWERED SUCTION PUMP

JCY — APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

BTA — PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)