BEUDAMED
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    PT. MEDISAFE TECHNOLOGIES

    FDA registration
    PT. MEDISAFE TECHNOLOGIES·1 product·🇮🇩 Indonesia

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM CORE 2.0

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM CORE-M 2.0

    FMR1 CGG PCR

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Beijing Healthgene Laboratory Co.,Ltd·1 device

    FMR1 CGG PCR

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Beijing Healthgene Laboratory Co.,Ltd·1 device

    Herpes Simplex Virus-Ⅱ IgG(HSV-Ⅱ IgG) Assay Reagent Kit(CMIA)

    Device
    EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

    Herpes Simplex Virus -Ⅰ IgG (HSV-Ⅰ IgG) Assay Reagent Kit (CMIA)

    Device
    EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

    Herpes Simplex Virus -Ⅰ IgG (HSV-Ⅰ IgG) Assay Reagent Kit (CMIA)

    Device
    EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·On the market

    Herpes Simplex Virus -Ⅱ IgG (HSV-Ⅱ IgG) Assay Reagent Kit (CMIA)

    Device
    EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·On the market

    IgG Screen Nutritional BGR44 ELISA

    Device
    EU IVDD · Eu Ivd General ·Gold Standard Diagnostics Kassel GmbH·On the market

    COVID-19 IgG Test Kit

    Device
    EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

    COVID-19 IgG Rapid Test

    Device
    EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·On the market

    Sharay Anti-sp100 IgG (CLIA)

    Device
    EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

    Sharay Anti-MPO IgG (CLIA)

    Device
    EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

    Sharay Anti-PR3 IgG (CLIA)

    Device
    EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

    Sharay Anti-GBM IgG (CLIA)

    Device
    EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

    Sharay Anti-ssDNA IgG (CLIA)

    Device
    EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

    Sharay Anti-dsDNA IgG (CLIA)

    Device
    EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

    Sharay Anti-Sm IgG (CLIA)

    Device
    EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

    Sharay Anti-Nuc IgG (CLIA)

    Device
    EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market