Results for “DREAM + HypnoVR System”

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Registry EUDAMED 29 FDA 510(k) incl. De Novo FDA PMA GUDID

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Risk class Class I 20 Class IIa 9 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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DREAM + HypnoVR Biofeedback System

Ybia SAS,France Group of variants

Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:IIa
DREAM + HypnoVR System

Ybia SAS,France Group of variants

Active Regimes: CE MDR Registry: EUDAMED Class:I

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Results for “DREAM + HypnoVR System”

Category (EMDN)

DREAM + HypnoVR Biofeedback System

DREAM + HypnoVR System