BEUDAMED
    12 results · 7ms · Sources: EU EUDAMED, US FDA

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    RESPIRATORY MASKS - OTHER

    Device
    EU MDR · Eu Md Class 1 ·Flying Tooling Engineering Limited·On the market·32 countries

    BigEasy® Non-Rebreathing Valve and Mask Kit

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Flying Tooling Engineering Limited·1 device

    DZ 2081692-1

    Certificate
    MDR QA·Hefei C&P Nonwoven Products Co.,Ltd·TÜV Rheinland LGA Products GmbH

    1434-IVDD-038/2022

    Certificate
    IVDD Annex III Section 6·BioDetect（Xiamen）Biotechnology Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs

    1434-IVDD-010/2022

    Certificate
    IVDD Annex III Section 6·Jiangsu Mole Bioscience Co., LTD.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

    HZ 2068488-1

    Certificate
    MDR QMS·Changsha Sinocare Inc.·TÜV Rheinland LGA Products GmbH

    No. V1 060250 0017

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Changsha Sinocare Inc.·TÜV SÜD Product Service GmbH·9 Basic UDI-DIs

    No. V1 060250 0017

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Changsha Sinocare Inc.·TÜV SÜD Product Service GmbH·13 Basic UDI-DIs

    No.V1 0602500017

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Changsha Sinocare Inc.·TÜV SÜD Product Service GmbH·11 Basic UDI-DIs

    No. V1060250 0017

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Changsha Sinocare Inc.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

    V1 076482 0004

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Shanghai Chemtron Biotech Co., Ltd.·TÜV SÜD Product Service GmbH·7 Basic UDI-DIs

    No.V1 076482 0004

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Shanghai Chemtron Biotech Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI