Identity
- Trade Name
- ECG Cable EUDAMED
- Device Name
- ECG Cable EUDAMED
- Model / Reference
- CM-M01-001 EUDAMEDCM-M01-019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429081060 EUDAMED
- Basic UDI-DI
- 69454290CM002JV EUDAMED
- Direct Marketing DI
- 06945429081060 EUDAMED
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
ECG Cable by Shenzhen Comen Medical Instruments Co., LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69454290CM002JV | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c9884654-0875-4743-98cc-869fb4fd77ad 61 fields · synced Oct 7, 2026