Identity
- Trade Name
- Disposable ECG Electrode EUDAMED
- Device Name
- Disposable electrode EUDAMED
- Model / Reference
- 915W40 MEHECO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950689101861 EUDAMED
- Basic UDI-DI
- 69506891ECG001JA EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Electrocardiographic electrode, single-use
Disposable ECG Electrode by Shanghai Shenfeng Medical&Health Articles Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69506891ECG001JA | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Shenfeng Medical&Health Articles Co., Ltd
- EUDAMED SRN
- CN-MF-000012676
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9d68e99d-9ff9-4c54-8253-5d00be6259cf 61 fields · synced Jun 18, 2026