Identity
- Trade Name
- DESFI-DORMO EUDAMED
- Device Name
- Electrodos de desfibrilación con cable pediátricos EUDAMED
- Model / Reference
- EDC-P115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427734008454 EUDAMED
- Basic UDI-DI
- B-08427734008454 EUDAMED
- EMDN Code
- C020480 CARDIOVERSION AND EXTERNAL DEFIBRILLATION DEVICES - ACCESSORIES 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Wearable defibrillation system
Desfi-Dormo by Telic, S.A.U. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wearable defibrillation system.
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- Hospital Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
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- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08427734008454 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08427734008454 | Class I | Active |
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Manufacturer
- Manufacturer
- Telic, S.A.U.
- EUDAMED SRN
- ES-MF-000001853
Sources (1)
- EUDAMED 3b61e775-2bed-49a0-a7b6-44dae532843a 61 fields · synced Jun 19, 2026