HE Kommunikator light II Pro AssistiveExpress
by Humanelektronik GmbH Germany EUDAMED
Ref 100222223Model HE Kommunikator light II
EMDN Y214209
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426076432HEKOMMUNLIGHT2JB | Date24 Aug 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- HE Kommunikator light II GoTalkNow
- Model / Reference
- HE Kommunikator light II, 100222223
- Primary DI / UDI-DI
- 04260764320066
- Basic UDI-DI
- 426076432HEKOMMUNLIGHT2JB
- Direct Marketing DI
- 04260764320066
- EMDN Code
- Y214209 Alphabetic and symbolic communicators
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000013990
Other devices from Humanelektronik GmbH
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 a0447bff-06ea-41b1-9baa-51c2bdfd6deb