Helpieye Eyegaze
by Didacare S.R.L. EUDAMED
Active
Ref MS501Model HELPIEYE EYEGAZE
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805059373POECAA01HLPEGZCJ | Date23 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Helpieye Eyegaze 13, Helpieye Eyegaze 15, Helpieye Eyegaze 17, Helpieye Eyegaze 13 Kids, Helpieye Eyegaze 15 Kids, Helpieye Eyegaze 17 Kids
- Model / Reference
- HELPIEYE EYEGAZE, MS501
- Primary DI / UDI-DI
- 08050593730169
- Basic UDI-DI
- 805059373POECAA01HLPEGZCJ
- Direct Marketing DI
- 08050593730169
- EMDN Code
- Y214209 Alphabetic and symbolic communicators
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000029715
Other devices from Didacare S.R.L.
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