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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
- 06971018116998 EUDAMED
- Basic UDI-DI
- 697101811ECGCABLEL6 EUDAMED
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
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- 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 (1)
- EUDAMED e9018476-0ee5-4234-9115-b6b99a0bcedf 61 fields · synced Jun 19, 2026