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ECG leadwire
EUDAMEDClass I (EU MDR)
Ref 10-lead ECG split line, 4.0 banana insert, European standard
Identity
- Trade Name
- ECG leadwire EUDAMED
- Device Name
- ECG leadwire EUDAMED
- Model / Reference
- 10-lead ECG split line, 4.0 banana insert, European standard EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971083647335 EUDAMED
- Basic UDI-DI
- 697108364420101102KJ EUDAMED
- Direct Marketing DI
- 06971083647335 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 81ae02c9-c6c1-4a3a-b7c7-23ee96408435 61 fields · synced Jun 5, 2026