89 results · 20ms · Sources: EU EUDAMED, US FDA

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MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA

FDA 510(k)
FDA Class 2 ·General Hospital

Wetling EU ApS

Manufacturer
🇩🇰 Denmark·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH

Re5 ApS

Manufacturer
🇩🇰 Denmark·5 Basic UDI-DIs·5 Devices·DNV Product Assurance AS

XO CARE A/S

Manufacturer
🇩🇰 Denmark·5 Basic UDI-DIs·5 Devices·DNV Product Assurance AS and DNV Product Assurance AS

NRT X-Ray A/S

Manufacturer
🇩🇰 Denmark·6 Basic UDI-DIs·6 Devices·DNV Product Assurance AS and DNV Product Assurance AS

Cortrium ApS

Manufacturer
🇩🇰 Denmark·4 Basic UDI-DIs·4 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

BIBAWO Medical A/S

Manufacturer
🇩🇰 Denmark·2 Basic UDI-DIs·4 Devices·DNV Product Assurance AS

Cardia International A/S

Manufacturer
🇩🇰 Denmark·5 Basic UDI-DIs·5 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

Hedia ApS

Manufacturer
🇩🇰 Denmark·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH

DDD-Diagnostic A/S

Manufacturer
🇩🇰 Denmark·6 Basic UDI-DIs·6 Devices·DNV Product Assurance AS

MedArt ApS

Manufacturer
🇩🇰 Denmark·1 Basic UDI-DI·1 Device·GMED SAS

Reapplix A/S

Manufacturer
🇩🇰 Denmark·1 Basic UDI-DI·1 Device·Eurofins Electric & Electronics Finland Oy

Vingmed A/S

Importer
🇩🇰 Denmark·27 Manufacturers

G20220650012

Certificate
MDD Annex V·Wetling EU ApS·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

10000377141-PA-NA-DNK

Certificate
MDD Annex V·Re5 ApS·DNV Product Assurance AS·4 Basic UDI-DIs

G1 098327 0004

Certificate
MDD Annex II (excluding section 4)·Cortrium ApS·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

G1 098327 0004

Certificate
MDD Annex II (excluding section 4)·Cortrium ApS·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

C-01-1210-718-19

Certificate
MDD Annex II (excluding section 4)·Reapplix A/S·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI

18166

Certificate
MDD Annex II (excluding section 4)·MedArt ApS·GMED SAS·1 Basic UDI-DI

G11054380002

Certificate
MDD Annex II (excluding section 4)·Hedia ApS·TÜV SÜD Product Service GmbH·1 Basic UDI-DI