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.

Fosun Diagnostics (Shanghai) Co., Ltd.

Manufacturer

🇨🇳 China·5 Basic UDI-DIs·5 Devices·CeCert Sp. z o.o.

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market·3 countries

Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device

EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market

Covid-19 Antigen CARD Kit

Device

EU IVDD · Eu Ivd Self Testing ·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market

Covid-19 Antigen CARD Kit

Device

EU IVDD · Eu Ivd Self Testing ·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market

Covid-19 Antigen CARD Kit

Device

EU IVDD · Eu Ivd Self Testing ·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·1 device

Covid-19 Antigen CARD Kit

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Fosun Diagnostics (Shanghai) Co., Ltd.·1 device

Covid-19 Antigen CARD Kit

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Fosun Diagnostics (Shanghai) Co., Ltd.·1 device

Covid-19 Antigen CARD Kit

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Fosun Diagnostics (Shanghai) Co., Ltd.·1 device

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