3,689 results
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9ms
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Sources: EU EUDAMED, US FDA
Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
Nucleic Acid Extraction System
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Sansure Biotech Inc.·1 device
Nucleic Acid Analysis Device
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Sansure Biotech Inc.·1 device
Fully Automated Nucleic Acid Extraction System
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Sansure Biotech Inc.·1 device
Portable Molecular Workstation
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Sansure Biotech Inc.·2 devices
Nucleic Acid Extraction System
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Sansure Biotech Inc.·3 devices
No. V1 074552 0011 Rev. 02
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs
CeCert/115/W/E.1
Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/116/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/117/W/E.1
Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/118/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/119/W/E.1
Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
CeCert/120/W/E.1
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
1434-IVDD-260/2022
Certificate
IVDD Annex III Section 6·Sansure Biotech Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·4 Basic UDI-DIs
Human Micro-albuminuria (mALB) Detection Kit(Nephelometry)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Human Micro-albuminuria (mALB) Detection Kit (Nephelometry)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Ferritin (FER) Test Kit (Immunofluorescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Ferritin (FER) Test Kit (Immunofluorescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device