Identity
- Trade Name
- Defibrillation Electrodes EUDAMED
- Device Name
- Defibrillation Electrodes EUDAMED
- Model / Reference
- OBS-DE/P EUDAMEDOBS-DE/Z1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939411509748 EUDAMED
- Basic UDI-DI
- 69394115OBS-DEQ3 EUDAMED
- EMDN Code
- C020401 EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Defibrillation Electrodes by Baisheng Medical Co., Ltd. — 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 | 69394115OBS-DEQ3 | Class I | Active |
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Manufacturer
- Manufacturer
- Baisheng Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000024558
- Authorised Representative
- Gardien Limited IE-AR-000034828
Sources (1)
- EUDAMED 956b8fd2-d631-47bb-8152-f7a6090c7823 61 fields · synced Jun 19, 2026