1,816 results · 32ms · Sources: EU EUDAMED, US FDA

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Needle, Emergency Airway

FDA classification
FDA Class 2 ·Needle, Emergency Airway

Controller, Temperature, Cardiopulmonary Bypass

FDA classification
FDA Class 2 ·Controller, Temperature, Cardiopulmonary Bypass

sthemO LA QC 1&2

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Diagnostica Stago·1 device

sthemO UFH QC 1&2

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

sthemO LMWH QC 1&2

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

sthemO FDP QC 1&2

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Diagnostica Stago·1 device

sthemO DDi QC 1&2

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

AXP QC Bag Set

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Thermogenesis Corp.·1 device

sthemO Complete QC 1&2

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

sthemO Daily QC 1&2

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

SpectroFlo® QC Beads

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Cytek Biosciences Inc.·1 device

Access Hybritech p2PSA (QC)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

Access Hybritech PSA (QC)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

Access Inhibin A (QC)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·1 device

Access anti-HCV QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Beckman Coulter Inc.·1 device

WASP QC TSB Tube

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Copan Wasp S.r.l.·1 device

Access HBc Ab QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Beckman Coulter Inc.·1 device

Access Inhibin A QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Beckman Coulter Inc.·1 device

Access HBs Ag QC

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Beckman Coulter Inc.·1 device