Identity
- Trade Name
- Desfi-Dormo EUDAMED
- Device Name
- Set of two adhesive pre-gelled pads EUDAMEDElectrodos de desfibrilación con cable para paciente Pediátrico EUDAMED
- Model / Reference
- EDC-P115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427734038680 EUDAMED
- Basic UDI-DI
- 8427734DFELECW/OCABLEADF2 EUDAMEDB-08427734038680 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
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
Category: Wearable defibrillation system
Desfi-Dormo by Telic, S.A.U. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wearable defibrillation system.
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
- Hospital Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
- Hospital Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
- Hospital Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
- LifeVest Wearable Defibrillator — ZOLL Manufacturing Corporation · Class III
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8427734DFELECW/OCABLEADF2 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8427734DFELECW/OCABLEADF2 | Class I | Active |
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Manufacturer
- Manufacturer
- Telic, S.A.U.
- EUDAMED SRN
- ES-MF-000001853
Sources (2)
- EUDAMED 76c9324b-c4d2-4368-a1d7-82024db4373d 61 fields · synced Jun 19, 2026
- EUDAMED c87fb35a-723f-413b-8d6f-f81013f91c8d 61 fields · synced Jun 19, 2026