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Brailliant BI 20X
EUDAMEDClass I (EU MDR)
Ref FGBR-1018Model Digital talking book
Identity
- Trade Name
- Brailliant BI 20X EUDAMED
- Device Name
- Digital talking book EUDAMED
- Model / Reference
- Digital talking book EUDAMEDFGBR-1018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18306110000398 EUDAMED
- Basic UDI-DI
- 83061100002JB EUDAMED
- EMDN Code
- Y210999 PERSONAL COMPUTER INPUT AND OUTPUT PERIPHERAL EQUIPMENT - OTHER 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
Brailliant BI 20X 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 (1)
- EUDAMED 9acbb880-7dce-40a4-9f11-f401e8154883 61 fields · synced Jun 18, 2026