17 results
·
8ms
·
Sources: EU EUDAMED, US FDA
SUPPLEMENTAL NA REAGENTS
Device
EU IVDR
·
Eu Ivd Class A
·BioTeke Corporation（Wuxi）Co., Ltd·On the market·27 countries
CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Laihe Biotech Co., Ltd.·On the market
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]
Device
EU IVDR
·
Eu Ivd Class C
·Hangzhou Laihe Biotech Co., Ltd.·On the market·1 country
1434-IVDD-010/2022
Certificate
IVDD Annex III Section 6·Jiangsu Mole Bioscience Co., LTD.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs
HL 2101523-1
Certificate
IVDD Annex IV (excluding sections 4, 6)·W.H.P.M. Bioresearch & Technology Co., Ltd.·TÜV Rheinland LGA Products GmbH·21 Basic UDI-DIs
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
HX 2074650-1
Certificate
IVDR QMS·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH
HL 2074650-1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs
2020-IVD/DE-006/A
Certificate
IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·3EC International a.s.·1 Basic UDI-DI
CeCert/081/W/E.4
Certificate
IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
1434-IVDD-078/2022
Certificate
IVDD Annex III Section 6·Assure Tech. (Hangzhou) Co., Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·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
HL 202746520-1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
HL 202746520-1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
CeCert/100/W/E.1
Certificate
IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/025/W/E.1
Certificate
IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/036/W/E.1
Certificate
IVDD Annex III Section 6·Hangzhou Realy Tech Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI