2,304 results · 43ms · Sources: EU EUDAMED, US FDA

Oragene Dx

FDA UDI
DNA Genotek Inc·00627595000248·DNA Specimen Collection, Saliva

COBAS INTEGRA REAGENT CASSETTES

FDA registration
ROCHE DIAGNOSTICS GMBH·13 products·🇩🇪 Germany

Oil Red O

FDA classification
FDA Class 1 ·Oil Red O

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS CL Foldable Silicone Intraocular Lens

Media, Mounting, Oil Soluble

FDA classification
FDA Class 1 ·Media, Mounting, Oil Soluble

TomoCon PACS

Basic UDI-DI
EU MDD · Eu Md Class 2b ·TatraMed Software s.r.o.·1 device

Olive Oil Emulsion (Turbidimetric), Lipase

FDA classification
FDA Class 1 ·Olive Oil Emulsion (Turbidimetric), Lipase

Oil Emulsion/Thymolphthalein (Titrimetric), Lipase

FDA classification
FDA Class 1 ·Oil Emulsion/Thymolphthalein (Titrimetric), Lipase

Electrode, Ion Based, Enzymatic, Creatinine

FDA classification
FDA Class 2 ·Electrode, Ion Based, Enzymatic, Creatinine

Ige, Rhodamine, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Ige, Rhodamine, Antigen, Antiserum, Control

RIC5-9A-RS

Basic UDI-DI
EU MDR · Eu Md Class 2a ·GE Healthcare Austria GmbH & Co OG·1 device

RAB6-RS

Basic UDI-DI
EU MDR · Eu Md Class 2a ·GE Healthcare Austria GmbH & Co OG·1 device

C2-9-RS

Basic UDI-DI
EU MDR · Eu Md Class 2a ·GE Healthcare Austria GmbH & Co OG·1 device

IC9-RS

Basic UDI-DI
EU MDR · Eu Md Class 2a ·GE Healthcare Austria GmbH & Co OG·1 device

Voluson Expert 18, Voluson Expert 20, Voluson Expert 22

Basic UDI-DI
EU MDR · Eu Md Class 2a ·GE Healthcare Austria GmbH & Co OG·8 devices

RIC10-D

Basic UDI-DI
EU MDR · Eu Md Class 2a ·GE Healthcare Austria GmbH & Co OG·1 device

4D View 18

Basic UDI-DI
EU MDR · Eu Md Class 2a ·GE Healthcare Austria GmbH & Co OG·1 device

Voluson Expert 18, Voluson Expert 20, Voluson Expert 22

Basic UDI-DI
EU MDR · Eu Md Class 2a ·GE Healthcare Austria GmbH & Co OG·2 devices

i-STAT CHEM8+ cartridge with the i-STAT 1 System

FDA registration
ABBOTT POINT OF CARE INC.·9 products·🇺🇸 United States

i-STAT CHEM8+ cartridge with the i-STAT 1 System

FDA registration
ABBOTT POINT OF CARE CANADA LIMITED·9 products·🇨🇦 Canada