Results for “AlphaScope”

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Registry EUDAMED 81 FDA 510(k) incl. De Novo 1 FDA PMA GUDID 1

Country / market European Union (all) 80 United States 2

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Germany 80

Risk class Class I 8 Class IIa 73 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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AlphaScope

SCHÖLLY FIBEROPTIC GmbH,Germany Group of variants

Expiring Regimes: CE MDR Registry: EUDAMED Class:IIa

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