3,934 results
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36ms
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Sources: EU EUDAMED, US FDA
PSA Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device
fPSA Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device
Colloidal Gold Reader
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device
AutoLumo analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·1 device
HIV Self Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Atomo Diagnostics Limited·1 device
AmoyDx® FFPE DNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
AmoyDx® Circulating DNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
AmoyDx® FFPE RNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
AmoyDx® Blood/Bone Marrow DNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
AmoyDx® Tissue RNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
HIV Self Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Atomo Diagnostics Limited·1 device
AmoyDx® FFPE DNA/RNA Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Amoy Diagnostics Co., LTD.·1 device
KDHT
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Yelatma Instrument-Making Enterprise Joint-Stock Company·1 device
EDPO
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Yelatma Instrument-Making Enterprise Joint-Stock Company·11 devices
EKa(p)DH
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Yelatma Instrument-Making Enterprise Joint-Stock Company·2 devices
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
QMD Services GmbH
Notified body
🇦🇹 Austria·6 Manufacturers·1 Basic UDI-DI
DGM-0549
Certificate
IVDD Annex IV (excluding sections 4, 6)·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI