Certificates in EUDAMED

Browse CE certificates issued by Notified Bodies under MDR and IVDR.

Document type

Certificate status

IssuedSupplementedAmendedWithdrawnReissuedCancelledRestrictedSuspendedReinstated

Certificate type

MDR certificates

Quality management systemTechnical documentationType examinationQuality assuranceProduct verification

IVDR certificates

Quality management systemTechnical documentationType examinationQuality assuranceProduction quality assurance

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]AIMDD [Directive 90/385/EEC on active implantable medical devices]MDD [Directive 93/42/EEC on medical devices]IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Risk class

Class IClass IIaClass IIbClass IIIIVDR Class AIVDR Class BIVDR Class CIVDR Class DIVDD — GeneralIVDD — Annex II List AIVDD — Annex II List BIVDD — Self-testingAIMDD

Manufacturer country

AustriaBelgiumBulgariaCroatiaCyprusCzechiaDenmarkEstoniaFinlandFranceGermanyGreeceHungaryIcelandIrelandItalyLatviaLiechtensteinLithuaniaLuxembourgMaltaNetherlandsNorwayPolandPortugalRomaniaSlovakiaSloveniaSpainSwedenSwitzerlandUnited Kingdom

Notified body country

Languages

BulgarianCroatianCzechDanishDutchEnglishEstonianFinnishFrenchGermanGreekHungarianIcelandicIrishItalianLatvianLithuanianMalteseNorwegianPolishPortugueseRomanianSlovakSlovenianSpanishSwedish

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3379 certificates in EUDAMED

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Document type

Certificate status

IssuedSupplementedAmendedWithdrawnReissuedCancelledRestrictedSuspendedReinstated

Certificate type

MDR certificates

Quality management systemTechnical documentationType examinationQuality assuranceProduct verification

IVDR certificates

Quality management systemTechnical documentationType examinationQuality assuranceProduction quality assurance

Applicable legislation

Risk class

Class IClass IIaClass IIbClass IIIIVDR Class AIVDR Class BIVDR Class CIVDR Class DIVDD — GeneralIVDD — Annex II List AIVDD — Annex II List BIVDD — Self-testingAIMDD

Manufacturer country

Notified body country

Languages

BulgarianCroatianCzechDanishDutchEnglishEstonianFinnishFrenchGermanGreekHungarianIcelandicIrishItalianLatvianLithuanianMalteseNorwegianPolishPortugueseRomanianSlovakSlovenianSpanishSwedish

Issue date

AfterBefore

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Results Found

~3,379 documents indexed

1 / 169

DynaMedic Co., Ltd.

Certificate 2026-MDR/QS-024Rev. 00

Issued

Certificate type

Quality management system

Notified body

3EC International a.s.

Version

Valid from

4/24/2026

Valid until

6/19/2028

ProSpon, spol. s r.o.

Certificate 2026-MDR/QS-032Rev. 00

Issued

Certificate type

Quality management system

Notified body

3EC International a.s.

Version

Valid from

5/22/2026

Valid until

5/22/2031

Qingdao Wearable Intelligent Medical Co.,Ltd.

Certificate HZ 2565917-1Rev. Rev.0

Issued

Certificate type

Quality management system

Notified body

TÜV Rheinland LGA Products GmbH

Version

Valid from

6/22/2026

Valid until

6/21/2031

CooperSurgical, Inc.

Certificate MDR 768166Rev. R001

Supplemented

Certificate type

Technical documentation

Notified body

BSI Group The Netherlands B.V.

Version

Valid from

6/8/2026

Valid until

10/6/2029

Biomet Microfixation

Certificate MDR 726882Rev. R002

Supplemented

Certificate type

Quality management system

Notified body

BSI Group The Netherlands B.V.

Version

Valid from

6/4/2026

Valid until

5/13/2031

Guangdong Baihe Medical Technology Co., Ltd

Certificate MDR 737797Rev. R001

Supplemented

Certificate type

Quality management system

Notified body

BSI Group The Netherlands B.V.

Version

Valid from

6/9/2026

Valid until

10/21/2029

LSI SOLUTIONS, Inc.

Certificate MDR 829377Rev. R001

Supplemented

Certificate type

Quality management system

Notified body

BSI Group The Netherlands B.V.

Version

Valid from

6/9/2026

Valid until

2/7/2028

Contipro a.s.

Certificate 2026-MDR/TD-031Rev. 00

Issued

Certificate type

Technical documentation

Notified body

3EC International a.s.

Version

Valid from

6/3/2026

Valid until

8/4/2028

Contipro a.s.

Certificate 2026-MDR/QS-031Rev. 00

Issued

Certificate type

Quality management system

Notified body

3EC International a.s.

Version

Valid from

6/3/2026

Valid until

8/4/2028

LEDFIX ELEKTRONIK TICARET ANONIM SIRKETI

Certificate 1984-MDR-00174210Rev. 00

Issued

Certificate type

Quality assurance

Notified body

Kiwa Belgelendirme Hizmetleri A.Ş.

Version

Valid from

6/25/2026

Valid until

6/24/2031

T.A.G. Medical products corporation LTD.

Certificate 40502Rev. 1

Supplemented

Certificate type

Quality management system

Notified body

GMED SAS

Version

Valid from

6/19/2026

Valid until

4/27/2031

Precisis Gesellschaft mit beschränkter Haftung

Certificate 2245875CE01Rev. 5

Supplemented

Certificate type

Quality management system

Notified body

DEKRA Certification B.V.

Version

Valid from

3/11/2024

Valid until

9/1/2027

Precisis Gesellschaft mit beschränkter Haftung

Certificate 2245875TD01Rev. 6

Restricted

Certificate type

Technical documentation

Notified body

DEKRA Certification B.V.

Version

Valid from

2/19/2026

Valid until

9/1/2027

Mastelli S.r.l.

Certificate CVD006326Rev. 00

Issued

Certificate type

Technical documentation

Notified body

ISTITUTO SUPERIORE DI SANITA'

Version

Valid from

6/26/2026

Valid until

6/25/2031

Mastelli S.r.l.

Certificate CSQ003726Rev. 00

Issued

Certificate type

Quality management system

Notified body

ISTITUTO SUPERIORE DI SANITA'

Version

Valid from

6/26/2026

Valid until

6/25/2031

Nakanishi Inc.

Certificate HZ 2002410-1Rev. 3

Issued

Certificate type

Quality management system

Notified body

TÜV Rheinland LGA Products GmbH

Version

Valid from

9/10/2024

Valid until

6/14/2027

Zhejiang Greylynx Biotech Co., Ltd.

Certificate IX 2566030-1Rev. Rev.0

Issued

Certificate type

Technical documentation

Notified body

TÜV Rheinland LGA Products GmbH

Version

Valid from

3/13/2025

Valid until

3/12/2030

Aerolite AG

Certificate G15 097666 0005Rev. Rev. 00

Reissued

Certificate type

Quality management system

Notified body

TÜV SÜD Product Service GmbH

Version

Valid from

9/20/2026

Valid until

9/19/2031

Shenzhen Aeon Technology Co., Ltd.

Certificate G15 073767 0021Rev. Rev. 00

Supplemented

Certificate type

Quality management system

Notified body

TÜV SÜD Product Service GmbH

Version

Valid from

6/22/2026

Valid until

4/4/2029

MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

Certificate G15 086916 0062Rev. Rev. 01

Supplemented

Certificate type

Quality management system

Notified body

TÜV SÜD Product Service GmbH

Version

Valid from

6/22/2026

Valid until

8/7/2028