6,259 results · 49ms · Sources: EU EUDAMED, US FDA

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

BD AESTHETIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

Importer
🇵🇱 Poland

Camp Scandinavia Oy

Importer
🇫🇮 Finland·8 Manufacturers

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

Biotronix Healthcare Gauze Sponges, N/S, 4"x4", 12 ply

FDA registration
BIOTRONIX HEALTHCARE INDUSTRIES INC.·1 product·🇺🇸 United States

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

DGM-458

Certificate
IVDD Annex IV Section 4·bioLytical Laboratories Inc.·Presafe Denmark A/S·1 Basic UDI-DI