BEUDAMED
    22 results · 7ms · 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.
    Filters Authorized Representative: Obelis S.A. ×

    Nucleix

    Manufacturer
    🇮🇱 Israel

    Sanway Gene Tech. Inc.

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·On the market·3 countries

    Osteopore International Pte Ltd

    Manufacturer
    🇸🇬 Singapore·5 Importers·TÜV Rheinland LGA Products GmbH

    B.J.ZH.F.Panther Medical Equipment Co., Ltd.

    Manufacturer
    🇨🇳 China·TÜV Rheinland LGA Products GmbH

    RF Medical Co., Ltd.

    Manufacturer
    🇰🇷 South Korea·10 Importers·SGS Belgium NV

    MANI, INC.

    Manufacturer
    🇯🇵 Japan·25 Importers·TÜV Rheinland LGA Products GmbH

    Promisemed Hangzhou Meditech Co., Ltd.

    Manufacturer
    🇨🇳 China·3 Basic UDI-DIs·7 Devices·8 Importers·TÜV Rheinland LGA Products GmbH

    Changsha Sinocare Inc.

    Manufacturer
    🇨🇳 China·1 Importer·TÜV Rheinland LGA Products GmbH

    OSSTEM IMPLANT Co., Ltd.

    Manufacturer
    🇰🇷 South Korea·1 Basic UDI-DI·1 Device·TÜV Rheinland LGA Products GmbH

    C-K DENTAL IND.CO.,LTD.

    Manufacturer
    🇰🇷 South Korea·6 Importers·SGS Belgium NV

    1434-IVDD-198/2022

    Certificate
    IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    1434-IVDD-199/2022

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

    Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·1 device

    HZ 2091024-1

    Certificate
    MDR QMS·Promisemed Hangzhou Meditech Co., Ltd.·TÜV Rheinland LGA Products GmbH

    HZ 2068842-1

    Certificate
    MDR QMS·Osteopore International Pte Ltd·TÜV Rheinland LGA Products GmbH

    HZ 2100551-1

    Certificate
    MDR QMS·MANI, INC.·TÜV Rheinland LGA Products GmbH

    HZ 2292034-1

    Certificate
    MDR QMS·OSSTEM IMPLANT Co., Ltd.·TÜV Rheinland LGA Products GmbH

    KR24/0000049

    Certificate
    MDR QMS·C-K DENTAL IND.CO.,LTD.·SGS Belgium NV

    HZ 2185282-1

    Certificate
    MDR QMS·B.J.ZH.F.Panther Medical Equipment Co., Ltd.·TÜV Rheinland LGA Products GmbH