Results for “UF(II) Internal Fixture”

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Registry EUDAMED 268 FDA 510(k) incl. De Novo FDA PMA GUDID 14

Country / market European Union (all) 254 United States 14

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Risk class Class I 28 Class IIa Class IIb 240 Class III Class II (US)

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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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UF(II) Internal Fixture

DIO Corporation,South Korea Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIb
UF(II) Internal DG Fixture Analog

DIO Corporation,South Korea

Active Regimes: CE MDR Registry: EUDAMED Class:I

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Results for “UF(II) Internal Fixture”

Category (EMDN)

UF(II) Internal Fixture

UF(II) Internal DG Fixture Analog