BEUDAMED
    1,031 results · 10ms · Sources: EU EUDAMED, US FDA

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    Model-A1

    Device
    EU MDR · Eu Md Class 1 ·BAIBYS Fertility Ltd.·On the market

    Spatz FGIA Inc.

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·1 Device·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

    BAIBYS™ System

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·BAIBYS Fertility Ltd.·1 device

    2125546CE01

    Certificate
    MDD Annex II (excluding section 4)·IOPtima Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI

    Shenzhen Microprofit Biotech Co., Ltd.

    Manufacturer
    🇨🇳 China·13 Basic UDI-DIs·13 Devices·9 Importers·CeCert Sp. z o.o., CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV SÜD Product Service GmbH

    LocaMed Ltd.

    Manufacturer
    3 Importers

    Hangzhou Alltest Biotech.Co.,Ltd.

    Manufacturer
    🇨🇳 China·119 Basic UDI-DIs·171 Devices·32 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.

    Manufacturer
    🇨🇳 China·6 Basic UDI-DIs·6 Devices·3 Importers·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Shenzhen Zijian Biotechnology Co., Ltd

    Manufacturer
    🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.

    WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.

    Manufacturer
    🇨🇳 China·3 Importers·TÜV Rheinland LGA Products GmbH

    Spatz3 Adjustable Balloon System

    Device
    EU MDD · Eu Md Class 2b ·Spatz FGIA Inc.·On the market·20 countries

    Incubator

    Device
    EU IVDR · Eu Ivd Class A ·Shenzhen Microprofit Biotech Co., Ltd.·On the market

    Dry-type Immunofluorescence Quantitative Analyzer

    Device
    EU IVDR · Eu Ivd Class A ·Shenzhen Microprofit Biotech Co., Ltd.·On the market

    SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)（Saliva）

    Device
    EU IVDD · Eu Ivd Self Testing ·Shenzhen Microprofit Biotech Co., Ltd.·On the market

    SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)

    Device
    EU IVDD · Eu Ivd Self Testing ·Shenzhen Microprofit Biotech Co., Ltd.·On the market

    SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)

    Device
    EU IVDD · Eu Ivd Self Testing ·Shenzhen Microprofit Biotech Co., Ltd.·On the market

    Free Prostate Specific Antigen (f-PSA) Diagnostic Kit

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Microprofit Biotech Co., Ltd.·On the market

    SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)

    Device
    EU IVDD · Eu Ivd Self Testing ·Shenzhen Microprofit Biotech Co., Ltd.·On the market·0 countries

    Free Prostate Specific Antigen (f-PSA) Diagnostic Kit

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Microprofit Biotech Co., Ltd.·On the market

    Prostate Specific Antigen (PSA) Diagnostic Kit

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Microprofit Biotech Co., Ltd.·On the market