11 results
·
9ms
·
Sources: EU EUDAMED, US FDA
Daan Gene Co., Ltd.
Manufacturer
🇨🇳 China·127 Basic UDI-DIs·194 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.
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
HEPATITIS C VIRUS - NA REAGENTS
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·On the market
HEPATITIS B VIRUS - NA REAGENTS
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·On the market
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
Diagnostic Kit for Quantification of Hepatitis C Virus RNA (PCR -Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·1 device
Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·1 device
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
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
CeCert/042/W/E.1
Certificate
IVDD Annex IV Section 4·Daan Gene Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/044/W/E.1
Certificate
IVDD Annex IV Section 4·Daan Gene Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI