73 results
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16ms
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Sources: EU EUDAMED, US FDA
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Huian Biosci Technology Co., Ltd.·On the market·2 countries
CLIN. CHEM. RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·On the market·1 country
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
SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Huian Biosci Technology Co., Ltd.·1 device
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
Vaginal pH Test Device
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
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.
2020-IVD/DE-006/A
Certificate
IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·3EC International a.s.·1 Basic UDI-DI
3EC International a.s.
Notified body
🇸🇰 Slovakia·97 Manufacturers·166 Basic UDI-DIs
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