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Results for “AlphaSMART”

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Registry EUDAMED 8 FDA 510(k) incl. De Novo FDA PMA GUDID 4

Country / market European Union (all) 8 United States 4

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Germany 8

Risk class Class I 6 Class IIa 2 Class IIb Class III Class II (US)

More classes (11)

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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8 devices foundsorted by relevance

DeviceDevice · Manufacturer · Authorizations Verified

Status

Regime

Registry

Class

AlphaSMART

Gimmi GmbH,Germany Group of variants

Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I
AlphaSMART DuoLap 50

WISAP Medical Technology GmbH,Germany

Active Regimes: CE MDR Registry: EUDAMED Class:IIa
AlphaSMART

SCHÖLLY FIBEROPTIC GmbH,Germany

Expiring Regimes: CE MDR Registry: EUDAMED Class:IIa
AlphaSMART Light Source

Gimmi GmbH,Germany Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I

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