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Bodies
Found : 50
Search criteria :
Legislation :
93/42/EEC Medical devices
Procedure /
Article or annex :
ALL
EC declaration of conformity (full quality assurance system) / Annex II
EC declaration of conformity (product quality assurance) / Annex VI
EC declaration of conformity (production quality assurance) / Annex V
EC type-examination / Annex III
EC verification / Annex IV
Full quality assurance system / Annex II (22/11/2010)
Product quality assurance / Annex VI (22/11/2010)
Production quality assurance / Annex V (22/11/2010)
Products :
ALL
*MD 0100 - General non-active, non-implantable medical devices
*MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
*MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
*MD 0103 - Non-active orthopaedic and rehabilitation devices
*MD 0104 - Non-active medical devices with measuring function
*MD 0105 - Non-active ophthalmologic devices
*MD 0106 - Non-active instruments
*MD 0107 - Contraceptive medical devices
*MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
*MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
*MD 0110 - Non-active medical devices for ingestion
*MD 0200 - Non-active implants
*MD 0201 - Non-active cardiovascular implants
*MD 0202 - Non-active orthopaedic implants
*MD 0203 - Non-active functional implants
*MD 0204 - Non-active soft tissue implants
*MD 0300 - Devices for wound care
*MD 0301 - Bandages and wound dressings
*MD 0302 - Suture material and clamps
*MD 0303 - Other medical devices for wound care
*MD 0400 - Non-active dental devices and accessories
*MD 0401 - Non-active dental equipment and instruments
*MD 0402 - Dental materials
*MD 0403 - Dental implants
*MD 1100 - General active medical devices
*MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
*MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
*MD 1103 - Devices for stimulation or inhibition
*MD 1104 - Active surgical devices
*MD 1105 - Active ophthalmologic devices
*MD 1106 - Active dental devices
*MD 1107 - Active devices for disinfection and sterilisation
*MD 1108 - Active rehabilitation devices and active prostheses
*MD 1109 - Active devices for patient positioning and transport
*MD 1110 - Active devices for in vitro fertilisation (IVF) and assisted reproductive therapy (ART)
*MD 1111 - Software
*MD 1112 - Medical gas supply systems and parts thereof
*MD 1200 - Devices for imaging
*MD 1201 - Imaging devices utilising ionizing radiation
*MD 1202 - Imaging devices utilising non-ionizing radiation
*MD 1300 - Monitoring devices
*MD 1301 - Monitoring devices of non-vital physiological parameters
*MD 1302 - Monitoring devices of vital physiological parameters
*MD 1400 - Devices for radiation therapy and thermo therapy
*MD 1401 - Devices utilising ionizing radiation
*MD 1402 - Devices utilising non-ionizing radiation
*MD 1403 - Devices for hyperthermia / hypothermia
*MD 1404 - Devices for (extracorporal) shock-wave therapy (lithotripsy)
*MDS 7001 - Medical devices incorporating medicinal substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal origin, including Regulation 722/2012 (Directive 2003/32/EC u...
*MDS 7003 - Medical devices incorporating derivates of human blood, according to Directive 2000/70/EC, amended by Dir...
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed
*MDS 7010 - Medical devices incorporating software /utilising software /controlled by software
Horizontal technical competence :
ALL
*MDS 7001 - Medical devices incorporating medicinal substances, according to Directive 2001/83/EC
*MDS 7002 - Medical devices utilising tissues of animal origin, including Regulation 722/2012 (Directive 2003/32/EC u...
*MDS 7003 - Medical devices incorporating derivates of human blood, according to Directive 2000/70/EC, amended by Dir...
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery
*MDS 7006 - Medical devices in sterile condition
*MDS 7007 - Medical devices utilising micromechanics
*MDS 7008 - Medical devices utilising nanomaterials
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed
*MDS 7010 - Medical devices incorporating software /utilising software /controlled by software
Withdrawn/Expired/Suspended Notifications/NBs are not displayed in this list, you can find them in the Body module under the hyperlink
"Withdrawn/Expired/Suspended Notifications/NBs"
Warning: As from 26 May 2021, the notified bodies designated under Directive 93/42/EEC as listed here are no longer able to issue new certificates under that Directive, but only allowed to carry out surveillance activities for certificates validly issued under that Directive in the transitional period, as established in Article 120 of Regulation (EU) 2017/745.
Body type
Name
Country
NB 2265
3EC International a.s.
Slovakia
NB 0318
AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
Spain
NB 2797
BSI Group The Netherlands B.V.
Netherlands
NB 1370
BUREAU VERITAS ITALIA S.P.A.
Italy
NB 0633
Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH
Germany
NB 2409
CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
Hungary
NB 0546
CERTIQUALITY S.r.l.
Italy
NB 1912
DARE!! Services B.V.
Netherlands
NB 0344
DEKRA Certification B.V.
Netherlands
NB 0124
DEKRA Certification GmbH
Germany
NB 2460
DNV Product Assurance AS
Norway
NB 0297
DQS Medizinprodukte GmbH
Germany
NB 1014
ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p.
Czech Republic
NB 1282
ENTE CERTIFICAZIONE MACCHINE SRL
Italy
NB 0537
Eurofins Expert Services Oy
Finland
NB 0681
Eurofins Product Service GmbH
Germany
NB 0477
Eurofins Product Testing Italy S.r.l.
Italy
NB 2803
G.F.I. Health Technology Certification Ltd
Cyprus
NB 0425
ICIM S.P.A.
Italy
NB 0051
IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
Italy
NB 1023
INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (merged with ex-NB 1390)
Czech Republic
NB 0413
INTERTEK SEMKO AB
Sweden
NB 0373
ISTITUTO SUPERIORE DI SANITA'
Italy
NB 0426
ITALCERT SRL
Italy
NB 0476
KIWA CERMET ITALIA S.P.A.
Italy
NB 1984
Kiwa Belgelendirme Hizmetleri A.Ş.
Turkey
NB 0483
MDC MEDICAL DEVICE CERTIFICATION GMBH
Germany
NB 0482
MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH
Germany
NB 0068
MTIC InterCert S.r.l.
Italy
NB 0653
NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY
Greece
NB 1011
NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)
Hungary
NB 0050
National Standards Authority of Ireland (NSAI)
Ireland
NB 2764
Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi
Turkey
NB 1434
POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Poland
NB 0402
RISE Research Institutes of Sweden AB
Sweden
NB 1639
SGS Belgium NV
Belgium
NB 0598 (ex-0403)
SGS FIMKO OY
Finland
NB 0494
SLG PRÜF UND ZERTIFIZIERUNGS GMBH
Germany
NB 1304
SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Slovenia
NB 1250
Schweizerische Vereinigung für Qualitäts- und Managementsysteme
Switzerland
(MRA)
NB 2195
Szutest Uygunluk Değerlendirme A.Ş.
Turkey
NB 0805
THERAPEUTIC GOODS ADMINISTRATION
Australia
(MRA)
NB 1783
TURKISH STANDARDS INSTITUTION (TSE)
Turkey
NB 2274
TUV NORD Polska Sp. z o.o
Poland
NB 1936
TUV Rheinland Italia SRL
Italy
NB 0044
TÜV NORD CERT GmbH
Germany
NB 0197
TÜV Rheinland LGA Products GmbH
Germany
NB 0123
TÜV SÜD Product Service GmbH Zertifizierstellen
Germany
NB 2292
UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.
Turkey
NB 2854
bqs. s.r.o.
Slovakia
European Commission - Growth