Certificates in EUDAMED

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

Certificate status

IssuedSupplementedAmendedWithdrawnReissuedCancelledRestrictedSuspendedReinstated

Certificate type

MDR certificates

Quality management systemTechnical documentationType examinationQuality assuranceProduct verification

IVDR certificates

Quality management systemTechnical documentationType examinationQuality 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

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Certificate status

IssuedSupplementedAmendedWithdrawnReissuedCancelledRestrictedSuspendedReinstated

Certificate type

MDR certificates

Quality management systemTechnical documentationType examinationQuality assuranceProduct verification

IVDR certificates

Quality management systemTechnical documentationType examinationQuality 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

8 9 10 11 12

Results Found

1,553 documents match your query

10 / 78

Enbio Technology Sp. z o. o.

Certificate TNP/MDR/0007/4332/2023Rev. Ver. 01

Issued

Certificate type

Quality management system

Notified body

2274

Version

Valid from

2/6/2023

Valid until

2/5/2026

Gebr. Brasseler GmbH & Co. KG

Certificate HZ 1470094-1Rev. Rev. 5

Supplemented

Certificate type

Quality management system

Notified body

0197

Version

Valid from

7/17/2025

Valid until

2/28/2026

neuroConn GmbH

Certificate G10 089300 0007Rev. Rev. 00

Issued

Certificate type

Quality management system

Notified body

0123

Version

Valid from

9/27/2023

Valid until

9/26/2028

COMITEK HOSPITAL PRODUCTS S.r.l.

Certificate 0425-MDR-030083-00Rev. 00

Issued

Certificate type

Quality assurance

Notified body

0425

Version

Valid from

7/1/2024

Valid until

6/30/2029

Global Biomedica s.r.o.

Certificate HZ 2574518-1Rev. 0

Issued

Certificate type

Quality management system

Notified body

0197

Version

Valid from

11/8/2024

Valid until

11/7/2029

Calopad AG

Certificate IT335406Rev. 1

Suspended

Certificate type

Quality management system

Notified body

1370

Version

Valid from

9/4/2024

Valid until

9/3/2029

Mathys AG Bettlach

Certificate G11 052905 0154Rev. Rev. 01

Issued

Certificate type

Quality management system

Notified body

0123

Version

Valid from

1/31/2025

Valid until

9/6/2026

Planmeca Oy

Certificate FI23/00000059Rev. Issue 6

Supplemented

Certificate type

Quality management system

Notified body

0598

Version

Valid from

9/17/2025

Valid until

6/26/2030

FREY SPÓŁKA JAWNA

Certificate 1434-MDR-005/2024Rev. 1 / 19.06.2024 / S/709/BM/2022

Issued

Certificate type

Quality management system

Notified body

1434

Version

Valid from

6/19/2024

Valid until

6/18/2029

ЖИВАС ООД

Certificate 2023-MDR/QS-057Rev. 00

Issued

Certificate type

Quality management system

Notified body

2265

Version

Valid from

12/1/2023

Valid until

12/1/2028

CARDIVAIS S.A.

Certificate ES23/00000553Rev. 1

Issued

Certificate type

Quality management system

Notified body

1639

Version

Valid from

5/30/2023

Valid until

5/30/2028

MEDITALIA S.R.L.

Certificate 0425-MDR-030187-00Rev. 00

Issued

Certificate type

Quality management system

Notified body

0425

Version

Valid from

5/4/2026

Valid until

5/3/2031

Joline GmbH & Co. KG

Certificate 50565-61-A2Rev. 1

Amended

Certificate type

Technical documentation

Notified body

0124

Version

Valid from

12/14/2021

Valid until

11/29/2025

3C-Medical Intelligence GmbH

Certificate G10 049632 0057Rev. Rev. 00

Issued

Certificate type

Quality management system

Notified body

0123

Version

Valid from

2/6/2024

Valid until

2/5/2029

Drillbone s.r.o.

Certificate 8801-MD-00001-24Rev. 01

Issued

Certificate type

Quality management system

Notified body

1383

Version

Valid from

12/3/2024

Valid until

12/2/2029

Sky Medical a.s.

Certificate ITH 1450762 1Rev. 2.0

Supplemented

Certificate type

Quality management system

Notified body

1936

Version

Valid from

6/6/2024

Valid until

11/22/2027

BÖSL Medizintechnik GmbH

Certificate HZ 1197161-1Rev. Rev. 1

Amended

Certificate type

Quality management system

Notified body

0197

Version

Valid from

12/8/2024

Valid until

5/9/2028

Aflofarm Farmacja Polska Sp. z o.o.

Certificate 1434-MDR-025/2024Rev. 1 /12.12.2024 / S/703/BM/2022

Issued

Certificate type

Technical documentation

Notified body

1434

Version

Valid from

12/12/2024

Valid until

12/11/2029

MEDSAN SP. Z O.O.

Certificate HZ 2598741-1Rev. 0

Issued

Certificate type

Quality management system

Notified body

0197

Version

Valid from

7/16/2025

Valid until

7/15/2030

LimFlow SA

Certificate 1000261596Rev. 01

Issued

Certificate type

Quality management system

Notified body

0297

Version

Valid from

8/21/2025

Valid until

10/26/2028