33544

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Z-17-172-P

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MDD_HD60148105 0001

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37790

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DD 1807535-1

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MDD Annex V·GILUPI GmbH·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

HD 60148105 0001

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System producer

🇭🇺 Hungary

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🇩🇪 Germany

botiss biomaterials GmbH

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System producer

🇩🇪 Germany

1434-IVDD-198/2022

Certificate

IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-199/2022

Certificate

IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·1 device

DGM-0549

Certificate

IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI

DGM-459

Certificate

IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·2 Basic UDI-DIs