66 results
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17ms
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Sources: EU EUDAMED, US FDA
CLIN. CHEM. RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·On the market·1 country
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
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
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
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
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Microprofit Biotech Co., Ltd.·On the market
SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay)
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Microprofit Biotech Co., Ltd.·On the market·0 countries
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 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
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