78 results · 8ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Merlin Biomedical (Xiamen) Co., Ltd.

Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.

Acon Biotech (Hangzhou) Co., Ltd.

Manufacturer
🇨🇳 China·101 Basic UDI-DIs·130 Devices·14 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Shenzhen Superbio Technology Co.,Ltd.

Manufacturer
🇨🇳 China·589 Basic UDI-DIs·591 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

SARS-CoV-2 Antigen Rapid Test Cassette

Device
EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·On the market

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

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)

Device
EU IVDD · Eu Ivd Self Testing ·Acon Biotech (Hangzhou) Co., Ltd.·On the market·32 countries

Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing)

Device
EU IVDD · Eu Ivd Self Testing ·Acon Biotech (Hangzhou) Co., Ltd.·On the market·32 countries

Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing)

Device
EU IVDD · Eu Ivd Self Testing ·Acon Biotech (Hangzhou) Co., Ltd.·On the market

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)

Device
EU IVDD · Eu Ivd Self Testing ·Acon Biotech (Hangzhou) Co., Ltd.·On the market·32 countries

Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing)

Device
EU IVDD · Eu Ivd Self Testing ·Acon Biotech (Hangzhou) Co., Ltd.·On the market·32 countries

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)

Device
EU IVDD · Eu Ivd Self Testing ·Acon Biotech (Hangzhou) Co., Ltd.·On the market·32 countries

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)

Device
EU IVDD · Eu Ivd Self Testing ·Acon Biotech (Hangzhou) Co., Ltd.·On the market·32 countries

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.

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

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

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

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

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

Device
EU IVDD · Eu Ivd Self Testing ·Shenzhen Superbio Technology 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