OneApp

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·1 device

CROS/BI-CROS transmitter

Basic UDI-DI

EU MDR · Eu Md Class 2a ·SBO Hearing A/S·21 devices

Bioprocen 22 R

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Álvarez Redondo, S.A.·1 device

CJ Jeon / KTR Europe GmbH

Authorized representative

🇩🇪 Germany

ChulJoo Jeon / KTR Europe GmbH

Authorized representative

🇩🇪 Germany

TandemLife LifeSPARC

FDA UDI

CARDIACASSIST, INC.·00814112020692·LifeSPARC Blood Pump, TandemLung Oxygenator, 17...

TandemLife LifeSPARC

FDA UDI

CARDIACASSIST, INC.·00814112020708·LifeSPARC Blood Pump, TandemLung Oxygenator, 15...

TandemLung LifeSPARC

FDA UDI

CARDIACASSIST, INC.·00814112020760·LifeSPARC Blood Pump, TandemLung Oxygenator, 31...

TandemLung LifeSPARC

FDA UDI

CARDIACASSIST, INC.·00814112020753·LifeSPARC Blood Pump, TandemLung Oxygenator, 29...

TandemLung LifeSPARC

FDA UDI

CARDIACASSIST, INC.·00814112020777·LifeSPARC Blood Pump, TandemLung Oxygenator, 31...

KR21/81826550

Certificate

MDD Annex II (excluding section 4)·Mediwhale, Inc·SGS Belgium NV·1 Basic UDI-DI

M.2019.106.11475

Certificate

MDD Annex II (excluding section 4)·J world Co., Ltd.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·40 Basic UDI-DIs

M.2020.106.13854

Certificate

MDD Annex V·YURIM MEDICAL Co., Ltd.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·5 Basic UDI-DIs

M.2019.106.11991

Certificate

MDD Annex II (excluding section 4)·YURIM MEDICAL Co., Ltd.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·14 Basic UDI-DIs

M.2016.106.7195

Certificate

MDD Annex II (excluding section 4)·YURIM MEDICAL Co., Ltd.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·18 Basic UDI-DIs

M.2016.106.7388

Certificate

MDD Annex II (excluding section 4)·BioMaterials Korea, Inc.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·112 Basic UDI-DIs

M.2016.106.7388

Certificate

MDD Annex II (excluding section 4)·BioMaterials Korea, Inc.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·1 Basic UDI-DI

2022-MDR/TD-023/A

Certificate

MDR Technical Documentation·Shin poong Pharm Co.,Ltd.·3EC International a.s.·1 Basic UDI-DI

9898-2017-CE-KOR-PS

Certificate

MDD Annex II (excluding section 4)·DIGIMED Co., Ltd.·DNV Product Assurance AS·1 Basic UDI-DI

C693394

Certificate

MDD Annex II (excluding section 4)·DIGIMED Co., Ltd.·DNV Product Assurance AS·3 Basic UDI-DIs