BEUDAMED
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    Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000

    FDA Enforcement
    Class II ·Terminated·Besmed Health Business Corporation·October 24, 2018

    SciVision Biotech Inc.

    System producer
    🇹🇼 Taiwan

    HD 2339568-1

    Certificate
    MDD Annex II (excluding section 4)·DELBIO INC.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

    HZ 1623480-1

    Certificate
    MDR QMS·Wellell Inc.·TÜV Rheinland LGA Products GmbH

    FI20/00010

    Certificate
    MDD Annex II (excluding section 4)·Leltek Inc.·DNV Product Assurance AS·2 Basic UDI-DIs

    FI2000010

    Certificate
    MDD Annex II Section 4·Leltek Inc.·SGS FIMKO OY·1 Basic UDI-DI

    HD2339568-1

    Certificate
    MDD Annex II (excluding section 4)·DELBIO INC.·TÜV Rheinland LGA Products GmbH·3 Basic UDI-DIs

    HD 2339568-1

    Certificate
    MDD Annex II (excluding section 4)·DELBIO INC.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

    TW19/20030

    Certificate
    MDD Annex II (excluding section 4)·Somnics, Inc.·SGS Belgium NV·2 Basic UDI-DIs

    TW24/00000261

    Certificate
    MDR QMS·Radiant Innovation Inc.·SGS Belgium NV

    No. V1 097447 0006

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·22 Basic UDI-DIs

    No. V1 097447 0006

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

    No. V1 097447 0006

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

    C-02-1073-797-22

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Tyson Bioresearch, Inc.·Eurofins Electric & Electronics Finland Oy·23 Basic UDI-DIs

    C-02-1073-797-22

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Tyson Bioresearch, Inc.·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI

    HD 60150337 0001

    Certificate
    MDD Annex II (excluding section 4)·Delta Electronics, Inc.·TÜV Rheinland LGA Products GmbH·3 Basic UDI-DIs

    TW19/20026

    Certificate
    MDD Annex II (excluding section 4)·Radiant Innovation Inc.·SGS Belgium NV·15 Basic UDI-DIs

    10000361344-PA-NA-TWN

    Certificate
    MDD Annex II Section 4·Innova Vision Inc.·DNV Product Assurance AS·1 Basic UDI-DI

    1434-MDD-136/2021

    Certificate
    MDD Annex II (excluding section 4)·Rolence Enterprise Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

    1434-MDD-135/2021

    Certificate
    MDD Annex II (excluding section 4)·Rolence Enterprise Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·9 Basic UDI-DIs