168 results
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10ms
·
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
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
Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer
🇨🇳 China·91 Basic UDI-DIs·115 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., 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.
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
MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Alltest Biotech.Co.,Ltd.·On the market
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Alltest Biotech.Co.,Ltd.·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Alltest Biotech.Co.,Ltd.·On the market
SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·On the market
SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Zijian Biotechnology Co., Ltd·On the market
COVID-19 (SARS-CoV-2) Antigen Test Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.·On the market