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Registry EUDAMED 62 FDA 510(k) incl. De Novo 1 FDA PMA GUDID 1

Country / market European Union (all) 62 United States 2

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France 62

Risk class Class I Class IIa Class IIb 1 Class III 61 Class II (US) 2

More classes (11)

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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64 devices foundsorted by relevance

Manufacturer: Hexacath× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

Rayflow

Hexacath,France

Active Regimes: CE MDD Registry: EUDAMED Class:IIb
Rayflow RFW62U

Hexacath,France

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

Hexacath,France

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

Hexacath,France Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:III

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