Dormo
Part of a family of 14 devices: see the family page
Ref SC-50
Dormo (SC-50) is a Class I device made by Telic, S.A.U., registered in EUDAMED on 28 Aug 2024 (Basic UDI-DI 8427734TENSELECJK), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8427734TENSELECJK 08427734006733 | Date28 Aug 2024 | StatusActive |
Official records
- EUDAMED public site 8427734TENSELECJK
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- Withdrawn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
- Pre-gelled muscle stimulation electrodes
- Model / reference
- SC-50
- Primary DI / UDI-DI
- 08427734006733
- Basic UDI-DI
- 8427734TENSELECJK
- EMDN code
- N010201 Tens system electrodes
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000001853
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