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Sources: EU EUDAMED, US FDA
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VCQ0951230013
Certificate
IVDD Annex IV (excluding sections 4, 6)·Hangzhou Alltest Biotech.Co.,Ltd.·TÜV SÜD Product Service GmbH·6 Basic UDI-DIs
No.V1095123 0008
Certificate
IVDD Annex IV (excluding sections 4, 6)·Hangzhou Alltest Biotech.Co.,Ltd.·TÜV SÜD Product Service GmbH·19 Basic UDI-DIs
CeCert/102/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Hangzhou Alltest Biotech.Co.,Ltd.·CeCert Sp. z o.o.·4 Basic UDI-DIs
VCQ0951230013 Rev.00
Certificate
IVDD Annex IV (excluding sections 4, 6)·Hangzhou Alltest Biotech.Co.,Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs
No.VCQ 095123 0013
Certificate
IVDD Annex IV (excluding sections 4, 6)·Hangzhou Alltest Biotech.Co.,Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
HX 2055510-1
Certificate
IVDR QMS·WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.·TÜV Rheinland LGA Products GmbH
CN23/00006997
Certificate
MDR QA·Shenzhen Zijian Biotechnology Co., Ltd·SGS Belgium NV
1434-IVDD-079/2022
Certificate
IVDD Annex III Section 6·WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·5 Basic UDI-DIs
1431-IVDD-079/2022
Certificate
IVDD Annex III Section 6·WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
CeCert/086/W/E.1
Certificate
IVDD Annex III Section 6·Shenzhen Zijian Biotechnology Co., Ltd·CeCert Sp. z o.o.·2 Basic UDI-DIs