BEUDAMED
    11 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.
    Filters Authorized Representative: Obelis S.A. ×

    KGM GLOVES SDN BHD

    Manufacturer
    🇲🇾 Malaysia

    Mozec™

    Device
    EU MDD · Eu Md Class 3 ·Meril Life Sciences Pvt. Ltd.·On the market·1 country

    Multi-unit Transfer Impression Coping

    Device
    EU MDR · Eu Md Class 1 ·MF / SEWONMEDIX Inc.·On the market

    Lineage™ NC

    Device
    EU MDD · Eu Md Class 3 ·Meril Life Sciences Pvt. Ltd.·On the market·1 country

    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

    Mozec™ - Rx PTCA Balloon Dilatation Catheter

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Meril Life Sciences Pvt. Ltd.·1 device

    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