ECG/EKG cable
EUDAMEDClass I (EU MDR)
Identity
- Trade Name
- ECG/EKG cable EUDAMED
- Device Name
- ECG/EKG cable EUDAMED
- Model / Reference
- C/K Series EUDAMEDClassification Rule Rule 1 in Chapter III of Annex VIII of the Regulation (EU) 2017/745 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971018110309 EUDAMED
- Basic UDI-DI
- 697101811ECGCABLEL6 EUDAMED
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Category: Electrocardiographic lead set, reusable
This ECG/EKG cable is a high-quality, FDA-compliant medical device designed for accurate and reliable electrocardiogram (ECG) or electrocardiograph (EKG) readings. Developed by Shanghai International Holding Corp. GmbH(Europe), it features a durable and easy-to-use design, making it an ideal choice for healthcare professionals and patients alike.
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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- 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
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 6e206f2c-5ad3-4b12-a15c-753cff013e03 61 fields · synced Jul 25, 2026