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Connect 12 FR w/ camera x25
EUDAMEDClass I (EU MDR)
Ref FGPG-1222Model Digital talking bookRef FGPG-1218
Identity
- Trade Name
- Connect 12 FR w/ camera x25 EUDAMEDConnect 12 FR EUDAMED
- Device Name
- Digital talking book EUDAMED
- Model / Reference
- Digital talking book EUDAMEDFGPG-1222 EUDAMEDFGPG-1218 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18306110000527 EUDAMED18306110000503 EUDAMED
- Basic UDI-DI
- 83061100002JB EUDAMED
- EMDN Code
- Y210603 VIDEO MAGNIFIERS 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
Connect 12 FR w/ camera x25 by Technologies HumanWare Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (2)
- EUDAMED 073c2588-28a9-4807-907d-61db731b6196 61 fields · synced Jul 23, 2026
- EUDAMED 64b7e160-07a5-4548-9051-fa3adb0c1d30 61 fields · synced May 18, 2026