← Back to catalogue
ECG leadwire
EUDAMEDClass I (EU MDR)
Ref D-type five-conductor cableRef Multifunctional cableRef LL type three-conductor cableRef Seven conductor cables
Identity
- Trade Name
- ECG leadwire EUDAMED
- Device Name
- ECG leadwire EUDAMED
- Model / Reference
- D-type five-conductor cable EUDAMEDMultifunctional cable EUDAMEDLL type three-conductor cable EUDAMEDSeven conductor cables EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971083645867 EUDAMED06971083646420 EUDAMED06971083645843 EUDAMED06971083646987 EUDAMED
- Basic UDI-DI
- 697108364420101102KJ EUDAMED
- Direct Marketing DI
- 06971083645867 EUDAMED06971083646420 EUDAMED06971083645843 EUDAMED06971083646987 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.
- Elektrody EKG — SORIMEX sp. z o.o. · Class I
- ECG — Zoll Medical Corporation · Class II
- SWAROMED — TYROLMED GmbH · Class II
- SWAROMED — TYROLMED GmbH · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen City Teveik Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018907
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (4)
- EUDAMED 2a93216a-0e1d-46f8-9280-c79680e21353 61 fields · synced Oct 6, 2026
- EUDAMED 2a1cbf31-b13b-4711-ba0a-eb2feaa8adff 61 fields · synced May 17, 2026
- EUDAMED 5ee46141-e04b-4c9d-b863-27474795ed8c 61 fields · synced May 17, 2026
- EUDAMED afe8f5b4-4bc2-4862-81d3-636a80695d94 61 fields · synced May 18, 2026