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Results for “ProXIma X6”

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Registry EUDAMED 5 FDA 510(k) incl. De Novo 1 FDA PMA GUDID 2

Country / market European Union (all) 5 United States 3

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Italy 5

Risk class Class I Class IIa Class IIb 5 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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6 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

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Regime

Registry

Class

ProXIma X6

CEFLA s.c.,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb
ProXIma X6

CEFLA s.c.,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
myray ProXIma X6

CEFLA s.c.,Italy

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

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