Fosun Diagnostics (Shanghai) Co., Ltd.

Manufacturer

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

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.

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

CORONAVIRUS [obsolete from 2025-01-01]

Device

EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

CORONAVIRUS [obsolete from 2025-01-01]

Device

EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

CORONAVIRUS [obsolete from 2025-01-01]

Device

EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

CORONAVIRUS [obsolete from 2025-01-01]

Device

EU IVDD · Eu Ivd Self Testing ·Sansure Biotech Inc.·On the market

1434-IVDD-224/2022

Certificate

IVDD Annex III Section 6·Beijing North Institute of Biotechnology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs

Beijing Strong Biotechnologies, Inc.

Manufacturer

🇨🇳 China·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH

JOYSBIO(Tianjin) Biotechnology Co., Ltd.

Manufacturer

🇨🇳 China·5 Basic UDI-DIs·5 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

Manufacturer

🇨🇳 China·91 Basic UDI-DIs·115 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Jiangsu Mole Bioscience Co., LTD.

Manufacturer

🇨🇳 China·85 Basic UDI-DIs·316 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Assure Tech. (Hangzhou) Co., Ltd.

Manufacturer

🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

BioDetect（Xiamen）Biotechnology Co., Ltd.

Manufacturer

🇨🇳 China·20 Basic UDI-DIs·20 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Manufacturer

🇨🇳 China·192 Basic UDI-DIs·192 Devices·1 Importer·CeCert Sp. z o.o.

Hangzhou Laihe Biotech Co., Ltd.

Manufacturer

🇨🇳 China·6 Basic UDI-DIs·6 Devices·2 Importers·CeCert Sp. z o.o. and TÜV Rheinland LGA Products GmbH

Xiamen Boson Biotech Co., Ltd.

Manufacturer

🇨🇳 China·160 Basic UDI-DIs·160 Devices·13 Importers·TÜV SÜD Product Service GmbH

Shenzhen Zijian Biotechnology Co., Ltd

Manufacturer

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