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Vr Stratus 12i Wifi 423vr Ce-Fifi
EUDAMEDClass I (EU MDR)
Ref FGSS-1058 Model Digital talking book
Identity
- Trade Name
- VR STRATUS 12I WIFI 423VR CE-FIFI EUDAMED
- Device Name
- Digital talking book EUDAMED
- Model / Reference
- Digital talking book EUDAMEDFGSS-1058 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18306110000664 EUDAMED
- Basic UDI-DI
- 83061100002JB EUDAMED
- EMDN Code
- Y212703 PAGE-TURNERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The VR STRATUS 12I WIFI 423VR CE-FIFI is a digital talking book designed for individuals with disabilities, providing accessible information and entertainment through immersive audio experiences. This device features advanced technologies such as wireless connectivity, microbial substances reduction, and comprehensive testing to ensure safety and reliability.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 83061100002JB | Class I | Active |
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Manufacturer
- Manufacturer
- Technologies HumanWare Inc.
- EUDAMED SRN
- CA-MF-000022852
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 69d2d455-2016-4412-bb47-b74d16bc096f 61 fields · synced Oct 6, 2026