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ECG leadwire
EUDAMEDClass I (EU MDR)
Ref Integrated five-lead wire, snap-type, European standard, 1K ohm.
Identity
- Trade Name
- ECG leadwire EUDAMED
- Device Name
- ECG leadwire EUDAMED
- Model / Reference
- Integrated five-lead wire, snap-type, European standard, 1K ohm. EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971083645935 EUDAMED
- Basic UDI-DI
- 697108364420101102KJ EUDAMED
- Direct Marketing DI
- 06971083645935 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
Category: Electrocardiographic electrode, single-use
ECG leadwire by Shenzhen City Teveik Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic electrode, single-use.
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- ECG — Zoll Medical Corporation · Class II
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- SWAROMED — TYROLMED GmbH · Class II
- PG10S /RU26 — FIAB S.p.A. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Kendall — Cardinalhealth · Class II
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 (2)
- EUDAMED 30bb6016-d58b-4739-8319-d9ed32b8cf9a 61 fields · synced Jul 10, 2026
- EUDAMED 30bb6016-d58b-4739-8319-d9ed32b8cf9a-1 61 fields · synced Jun 10, 2026