Results for “Single Use Optical Fiber Performance”

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Registry EUDAMED 7 FDA 510(k) incl. De Novo FDA PMA GUDID 2

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Italy 4 France 2 Germany 1

Risk class Class I Class IIa 7 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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Single Use Optical Fiber Performance

Quanta System S.p.A.,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa
Single Use Optical Fiber Performance

Quanta System S.p.A.,Italy Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:IIa

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