Identity
- Trade Name
- ECG Electrode EUDAMED
- Device Name
- ECG electrode EUDAMED
- Model / Reference
- ECG-A018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975585870390 EUDAMED
- Basic UDI-DI
- 697558587QDECGWV EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Category: Electrocardiographic electrode, single-use
ECG Electrode by Dongguan Quanding Medical Supplies Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Manufacturer's product page: ECG Electrodes
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 | 697558587QDECGWV | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Quanding Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000030836
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED c403ae5f-55d1-4d15-a2da-8c3526c1781f 61 fields · synced Oct 6, 2026