BEUDAMED
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    Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

    Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

    Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

    Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

    Nucleic Acid Extraction System

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Sansure Biotech Inc.·1 device

    Nucleic Acid Analysis Device

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Sansure Biotech Inc.·1 device

    Fully Automated Nucleic Acid Extraction System

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Sansure Biotech Inc.·1 device

    Portable Molecular Workstation

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Sansure Biotech Inc.·2 devices

    Nucleic Acid Extraction System

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Sansure Biotech Inc.·3 devices

    No. V1 074552 0011 Rev. 02

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs

    CeCert/115/W/E.1

    Certificate
    IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/116/W/E.1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/117/W/E.1

    Certificate
    IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/118/W/E.1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/119/W/E.1

    Certificate
    IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    CeCert/120/W/E.1

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

    1434-IVDD-260/2022

    Certificate
    IVDD Annex III Section 6·Sansure Biotech Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·4 Basic UDI-DIs