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ECG leadwire
EUDAMEDClass I (EU MDR)
Ref Integrated 10-lead wire, buckle type, American standard, 1K Europe.
Identity
- Trade Name
- ECG leadwire EUDAMED
- Device Name
- ECG leadwire EUDAMED
- Model / Reference
- Integrated 10-lead wire, buckle type, American standard, 1K Europe. EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971083646246 EUDAMED
- Basic UDI-DI
- 697108364420101102KJ EUDAMED
- Direct Marketing DI
- 06971083646246 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ECG leadwire by Shenzhen City Teveik Technology 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 | 697108364420101102KJ | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen City Teveik Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018907
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED e059d4cc-8d25-4779-9cd9-4dfa1da4a2fc 61 fields · synced Jun 5, 2026