Results for “SafetiHEEL”

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Registry EUDAMED 3 FDA 510(k) incl. De Novo 1 FDA PMA GUDID 3

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Risk class Class I Class IIa 2 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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SafetiHeel, MediHeel, Novaplus

Nsp Tech Pte, Ltd.,Singapore

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II
SafetiHEEL

Nsp Tech Pte, Ltd.,Singapore Group of variants

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

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Results for “SafetiHEEL”

Category (EMDN)

SafetiHeel, MediHeel, Novaplus

SafetiHEEL