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Sources: EU EUDAMED, US FDA
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1434-IVDD-217/2022
Certificate
IVDD Annex III Section 6·Hangzhou Alltest Biotech.Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
1434-IVDD-035/2022
Certificate
IVDD Annex III Section 6·Hangzhou Alltest Biotech.Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·2 Basic UDI-DIs
CeCert/097/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Hangzhou Alltest Biotech.Co.,Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
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
1434-IVDD-174/2022
Certificate
IVDD Annex III Section 6·Maccura Biotechnology Co., Ltd. ·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·28 Basic UDI-DIs
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