GoTalk
by Attainment Company, Inc. United States EUDAMED
Ref WEB1-GT-E07Model GoTalk
EMDN Y214212
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08600117268GTVJ | Date24 Sep 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- GoTalk Product Line
- Model / Reference
- GoTalk, WEB1-GT-E07
- Primary DI / UDI-DI
- 00860011726845
- Basic UDI-DI
- 08600117268GTVJ
- Direct Marketing DI
- 00860011726845
- EMDN Code
- Y214212 Voice generators
- Device Class
- Class I
- Market of Registration
- Malta
Manufacturer details
- EUDAMED SRN
- US-MF-000043650
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Attainment Company, 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 6d07dadf-c779-4f15-84e4-40d9355b0a87