BEUDAMED
    256 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Certificate Type: Ivdd Annex Iv (Excluding Sections 4, 6) ×

    Abon Biopharm(Hangzhou) Co., Ltd

    Manufacturer
    🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, GMED SAS, and GMED SAS

    Allergen Discs Bos d 8 (Casein)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Gold Standard Diagnostics Kassel GmbH·1 device

    HCV ANTIBODY -RT & POC

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

    HBSAG - RT & POC

    Device
    EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

    Allergen Discs Bos d 5 (Beta-Lactoglobulin)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Gold Standard Diagnostics Kassel GmbH·1 device

    Allergen Discs Bos d 4 (Alpha-Lactalbumin)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Gold Standard Diagnostics Kassel GmbH·1 device

    GB Lifecare Co., Ltd.

    Manufacturer
    🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·TÜV Rheinland LGA Products GmbH

    Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.

    Manufacturer
    🇨🇳 China·5 Basic UDI-DIs·5 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

    GC MEDIS Corp.

    Manufacturer
    🇰🇷 South Korea·31 Basic UDI-DIs·31 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

    SHANGHAI ZJ BIO-TECH CO., LTD

    Manufacturer
    🇨🇳 China·297 Basic UDI-DIs·326 Devices·2 Importers·TÜV Rheinland LGA Products GmbH

    Tosoh Corporation

    Manufacturer
    🇯🇵 Japan·388 Basic UDI-DIs·414 Devices·1 Importer·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    Sansure Biotech Inc.

    Manufacturer
    🇨🇳 China·1252 Basic UDI-DIs·1376 Devices·4 Importers·TÜV SÜD Product Service GmbH, CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Sanway Gene Tech. Inc.

    Manufacturer
    🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    Apex Biotechnology Corp.

    Manufacturer
    🇹🇼 Taiwan·40 Basic UDI-DIs·40 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    Atomo Diagnostics Limited

    Manufacturer
    🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach

    Manufacturer
    🇵🇱 Poland·30 Basic UDI-DIs·32 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

    HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

    HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device

    KET-1

    Device
    EU IVDD · Eu Ivd Self Testing ·Apex Biotechnology Corp.·No longer on the market

    Contrex Plus III

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Apex Biotechnology Corp.·On the market