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Is VR Fusion Trainer certified as a medical device?

VR Fusion Trainer by Talkingeyes & More GmbH is listed as a CE class I medical device. Class I is self-declared by the maker, without review by a notified body. We found no FDA authorisation.

At a glance

ProductVR Fusion Trainer
MakerTalkingeyes & More GmbH
Care areaEyes & vision
What it doesVirtual reality eye training software
FDANo FDA authorisation found
EU (CE)Class I (self-declared)
Websitetalkingeyes.de
StatusCE class I
Last checked7 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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