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Patient cables and Lead wires
EUDAMEDClass I (EU MDR)
Ref Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745Model C/K Series
Identity
- Trade Name
- Patient cables and Lead wires EUDAMED
- Device Name
- ECG/EKG cable EUDAMED
- Model / Reference
- C/K Series EUDAMEDRule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971018118893 EUDAMED06971018116899 EUDAMED06971018116882 EUDAMED06942730200326 EUDAMED06942730200319 EUDAMED06942730200340 EUDAMED06942730200333 EUDAMED
- Basic UDI-DI
- 697101811ECGCABLEL6 EUDAMED
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDBelgium 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 lead set, reusable
Patient cables and Lead wires by Shenzhen Medke Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · 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 | 697101811ECGCABLEL6 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Medke Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019638
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (7)
- EUDAMED 77189c95-2d6c-48e9-bdc0-f614fa2e6408 61 fields · synced Aug 4, 2026
- EUDAMED 6a0c6edb-f83e-4878-95bf-57c0faf2148a 61 fields · synced May 17, 2026
- EUDAMED 69e5a94a-3f9b-453a-9faa-4fcf587c9d2c 61 fields · synced May 17, 2026
- EUDAMED 49f5ff0d-11c2-4b46-a586-eb6ddcef2134 61 fields · synced May 18, 2026
- EUDAMED c5bca69e-23e4-4307-b315-ea427a0272bf 61 fields · synced May 19, 2026
- EUDAMED 5d23b760-10ca-4234-b982-a6648837bb56 61 fields · synced May 19, 2026
- EUDAMED e4580ea2-7c78-413e-af5c-7c42ee58065c 61 fields · synced May 19, 2026