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Registry EUDAMED 23 FDA 510(k) incl. De Novo 1 FDA PMA GUDID

Country / market European Union (all) 23 United States 1

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France 22 Germany 1

Risk class Class I 23 Class IIa Class IIb Class III Class II (US) 1

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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24 devices foundsorted by relevance

Manufacturer: Global Healthcare SG Sdn. Bhd× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

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Regime

Registry

Class

CarbonCool®

Global Healthcare SG Sdn. Bhd,Malaysia Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
Emcools®

Global Healthcare SG Sdn. Bhd,Malaysia

Active Regimes: CE MDR Registry: EUDAMED Class:I
CarbonCool® System

Global Healthcare SG Sdn. Bhd,Malaysia

Active Regimes: 510(k) Registry: 510(k) Class:II

Showing 21-24 of 24

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