14 results
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16ms
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Sources: EU EUDAMED, US FDA
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
Access anti-HCV
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Beckman Coulter Inc.·On the market·32 countries
Access anti-HCV Calibrator
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Beckman Coulter Inc.·On the market·32 countries
Access anti-HCV QC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Beckman Coulter Inc.·On the market·32 countries
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
765852
Certificate
IVDD Annex IV Section 4·Beckman Coulter Inc.·BSI Group The Netherlands B.V.·3 Basic UDI-DIs
Access anti-HCV Calibrator
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Beckman Coulter Inc.·1 device
Access anti-HCV QC
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Beckman Coulter Inc.·1 device
Access anti-HCV
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Beckman Coulter Inc.·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
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