Communicator
by Enabling Devices Inc. United States EUDAMED
Ref 4055Model Communicator
EMDN Y99
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number850079998CommunicatorAW | Date10 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Talkable 2
- Model / Reference
- Communicator, 4055
- Primary DI / UDI-DI
- 00850079998414
- Basic UDI-DI
- 850079998CommunicatorAW
- EMDN Code
- Y99 Devices for persons with disabilities not included in other categories - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- US-MF-000049616
- Authorised representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Other devices from Enabling Devices Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 60053cbc-ab57-4d3a-9326-f787c116fef8