Identity
- Trade Name
- Communicator EUDAMED
- Device Name
- Talkable 2 EUDAMED
- Model / Reference
- Communicator EUDAMED806 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850079998148 EUDAMED
- Basic UDI-DI
- 850079998CommunicatorAW EUDAMED
- EMDN Code
- Y99 DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Communicator by Enabling Devices 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 | 850079998CommunicatorAW | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Enabling Devices Inc.
- EUDAMED SRN
- US-MF-000049616
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED e8fa8dd4-93b2-4edb-9be5-90cd2ca6976b 61 fields · synced Jun 19, 2026