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Disposable Defibrillation Electrodes
EUDAMEDClass I (EU MDR)
Ref DE0001ARef DE0002A
Identity
- Trade Name
- Disposable Defibrillation Electrodes EUDAMED
- Device Name
- 除颤电极 EUDAMED
- Model / Reference
- DE0001A EUDAMEDDE0002A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944414074209 EUDAMED06944414084345 EUDAMED06944414000598 EUDAMED06944414078764 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 (4)
- EUDAMED a356f172-2f5f-4f7f-8df9-4e14a1bac874 61 fields · synced Aug 1, 2026
- EUDAMED ed9f55b8-4372-4823-9d18-a67a8d76f7f9 61 fields · synced Jul 9, 2026
- EUDAMED 08d4c2ec-e0b4-46a1-8e58-cf79e81af8c7 61 fields · synced Jul 28, 2026
- EUDAMED cf979d44-6365-46ce-8714-1028d26407a0 61 fields · synced Aug 1, 2026