346 results · 9ms · 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.

Labsystems Diagnostics Oy

Manufacturer
🇫🇮 Finland·74 Basic UDI-DIs·75 Devices·Eurofins Electric & Electronics Finland Oy, Eurofins Electric & Electronics Finland Oy, and Eurofins Electric & Electronics Finland Oy

Calpro AS

Manufacturer
🇳🇴 Norway·4 Basic UDI-DIs·4 Devices·Eurofins Electric & Electronics Finland Oy

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

Biocard™ Celiac Home

Device
EU IVDD · Eu Ivd Self Testing ·Labsystems Diagnostics Oy·On the market

CalproSmart Self-Test

Device
EU IVDD · Eu Ivd Self Testing ·Calpro AS·On the market·15 countries

Biocard™ H pylori IgG Home

Device
EU IVDD · Eu Ivd Self Testing ·Labsystems Diagnostics Oy·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

ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD

Manufacturer
🇨🇳 China·29 Basic UDI-DIs·29 Devices·4 Importers·Sertio Oy, TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

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.

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