Identity
- Trade Name
- Braille eMotion 40 EUDAMED
- Device Name
- Braille eMotion 40 EUDAMED
- Model / Reference
- B340T EUDAMEDSVHBR-B340T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08805116000614 EUDAMED
- Basic UDI-DI
- 8805116000614YT EUDAMED
- EMDN Code
- Y214299 DEVICES FOR INTERPERSONAL COMUNICATION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Braille eMotion 40 by SELVAS Healthcare, 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 | 8805116000614YT | Class I | Active |
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Manufacturer
- Manufacturer
- SELVAS Healthcare, Inc.
- EUDAMED SRN
- KR-MF-000019198
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 2d69ac84-2862-41df-94ba-3070b54a4105 61 fields · synced Jun 19, 2026