Results for “GENU-HiT”

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Registry EUDAMED 102 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 70

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Germany 70

Risk class Class I 102 Class IIa Class IIb 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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GENU-HiT SUPREME

SPORLASTIC GMBH & Co.KG,Germany

Active Regimes: CE MDR Registry: EUDAMED Class:I
GENU-HiT RS

SPORLASTIC GMBH & Co.KG,Germany

Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:I

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Results for “GENU-HiT”

Category (EMDN)

GENU-HiT SUPREME

GENU-HiT RS