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Disposable Defibrillation Electrodes
EUDAMEDClass I (EU MDR)
Ref DE0005AModel DE0001A
Identity
- Trade Name
- Disposable Defibrillation Electrodes EUDAMED
- Device Name
- 除颤电极 EUDAMED
- Model / Reference
- DE0001A EUDAMEDDE0005A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944414097079 EUDAMED
- Basic UDI-DI
- 69444140015SR EUDAMED
- EMDN Code
- C020401 EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Defibrillation Electrodes by Shenzhen Med-link Electronics Tech 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 | 69444140015SR | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Med-link Electronics Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000011145
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d1c60815-d1f9-4e3a-af96-6ab9bc9615e3 61 fields · synced Jun 14, 2026