Identity
- Trade Name
- DORMO EUDAMED
- Device Name
- Pre-gelled muscle stimulation electrodes EUDAMED
- Model / Reference
- RT-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427734002124 EUDAMED
- Basic UDI-DI
- 8427734TENSELECJK EUDAMED
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dormo by Telic, S.A.U. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8427734TENSELECJK | Class I | Active |
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Manufacturer
- Manufacturer
- Telic, S.A.U.
- EUDAMED SRN
- ES-MF-000001853
Sources (1)
- EUDAMED c899d069-9a19-4d2c-aa95-ac341248eeb3 61 fields · synced Jun 18, 2026