10 results
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17ms
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Sources: EU EUDAMED, US FDA
Sanway Gene Tech. Inc.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·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
1434-IVDD-198/2022
Certificate
IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Assure Tech. (Hangzhou) Co., Ltd.·On the market
SARS-CoV-2 Antigen Rapid Tests for Self-Testing
Device
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·On the market
HIV Rapid Test Device (Whole blood/Serum/Plasma)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
SARS-CoV-2 Antigen Rapid Tests for Self-Testing
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
CeCert/077/W/E.1
Certificate
IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
244409553-200
Certificate
IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI