Communicator
by Enabling Devices Inc. 24 variants
Ref 4202Model Communicator
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number850079998CommunicatorAW 00850079998322 | Date10 Oct 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Talkable 2
- Model / Reference
- Communicator, 4202
- Primary DI / UDI-DI
- 00850079998322
- Basic UDI-DI
- 850079998CommunicatorAW
- EMDN Code
- Y99 Devices for persons with disabilities not included in other categories - other
- Device Class
- Class I
- EU 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
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