731 results · 8ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

CareforU.Co.Ltd

Manufacturer
🇰🇷 South Korea·6 Basic UDI-DIs·6 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

PRP Science Co., Ltd.

Manufacturer
🇰🇷 South Korea·21 Basic UDI-DIs·21 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

BIO PROTECH INC.

Manufacturer
🇰🇷 South Korea·121 Basic UDI-DIs·121 Devices·7 Importers·DNV Product Assurance AS

DalimsurgNET corporation

Manufacturer
🇰🇷 South Korea·61 Basic UDI-DIs·61 Devices·SGS Belgium NV

AI INSIGHT INC.

Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

DMS CO., LTD.

Manufacturer
🇰🇷 South Korea·14 Basic UDI-DIs·14 Devices·Szutest Uygunluk Değerlendirme A.Ş.

SAESHIN PRECISION CO.,LTD.

Manufacturer
🇰🇷 South Korea·148 Basic UDI-DIs·148 Devices·3 Importers·SGS Belgium NV

BrainU Co.,Ltd.

Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·3EC International a.s.

1434-IVDD-178/2022

Certificate
IVDD Annex III Section 6·CareforU.Co.Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

1434-MDD-106/2021

Certificate
MDD Annex II Section 4·PRP Science Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·21 Basic UDI-DIs

1434-MDD-107/2021

Certificate
MDD Annex II Section 4·PRP Science Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·21 Basic UDI-DIs

10316-2017-CE-KOR-NA-PS

Certificate
MDD Annex II (excluding section 4)·BIO PROTECH INC.·DNV Product Assurance AS·118 Basic UDI-DIs

2021-MDD/QS-008

Certificate
MDD Annex II (excluding section 4)·BrainU Co.,Ltd.·3EC International a.s.·1 Basic UDI-DI

KR19/81826219

Certificate
MDD Annex II (excluding section 4)·DalimsurgNET corporation·SGS Belgium NV·61 Basic UDI-DIs

KR19/81826253

Certificate
MDD Annex II (excluding section 4)·SAESHIN PRECISION CO.,LTD.·SGS Belgium NV·148 Basic UDI-DIs

2195-MED-1317901

Certificate
MDD Annex II (excluding section 4)·DMS CO., LTD.·Szutest Uygunluk Değerlendirme A.Ş.·5 Basic UDI-DIs

1434-MDD-370/2021

Certificate
MDD Annex II (excluding section 4)·AI INSIGHT INC.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

CareBuddy

Device
EU IVDD · Eu Ivd Self Testing ·CareforU.Co.Ltd·On the market

CareBuddy

Device
EU IVDD · Eu Ivd Self Testing ·CareforU.Co.Ltd·On the market

OLIDIA

Device
EU MDD · Eu Md Class 3 ·PRP Science Co., Ltd.·On the market·3 countries