30 results · 10ms · 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.

Fosun Diagnostics (Shanghai) Co., Ltd.

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

Merlin Biomedical (Xiamen) Co., Ltd.

Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·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.

Shenzhen Superbio Technology Co.,Ltd.

Manufacturer
🇨🇳 China·589 Basic UDI-DIs·591 Devices·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

SARS-CoV-2 Antigen Rapid Test Cassette

Device
EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) 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

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

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/082/W/E.1

Certificate
IVDD Annex III Section 6·Fosun Diagnostics (Shanghai) Co., Ltd.·CeCert Sp. z o.o.·3 Basic UDI-DIs

SARS-CoV-2 Antigen Rapid Test Cassette

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·1 device