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Results for “KabiHelp Uno”

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Registry EUDAMED 14 FDA 510(k) 1 FDA PMA GUDID

Country / market European Union (all) 14 United States 1

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Germany 14

Risk class Class I 14 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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15 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

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Registry

Class

KabiHelp Uno

DIFFUPLAST srl,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
KabiHelp Uno LL

DIFFUPLAST srl,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I
KabiHelp® Uno; KabiHelp® Advance plus

Fresenius Kabi AG,Germany

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

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