Eu Mdr Eu Md Class 1 On The Market 🇳🇱 Netherlands

DeepTherapy

3DUniversum · 🇳🇱 Netherlands
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
87208926452104
Basic UDI-DI Code
10058387002H2
Reference
DeepTherapy.v1
Device Types
Reprocessed
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
3DUniversum

Additional Description

DeepTherapy is an online therapeutic communication platform enabling real-time, interactive role-playing therapy through therapist-controlled deepfake avatars. The platform is used in psychotherapy, trauma processing, grief counseling, mediation, and assertiveness training. The therapist fully controls the deepfake avatar, which functions as a simulated person in therapy (e.g., a deceased loved one, a perpetrator, or a conflict partner). The software does not autonomously generate responses but instead functions as a tool operated by the therapist to facilitate therapeutic interventions.

CND Nomenclature Codes

Code Description
V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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