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Results for “FastStroke”

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Registry EUDAMED 3 FDA 510(k) incl. De Novo 2 FDA PMA GUDID

Country / market European Union (all) 3 United States 2

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France 3

Risk class Class I Class IIa 3 Class IIb Class III Class II (US) 2

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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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5 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

FastStroke

GE Medical Systems SCS,France Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
FastStroke

Gef Medical Systems Scs,France(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:II
FastStroke, CT Perfusion 4D

GE Medical Systems SCS,France

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

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