Identity
- Trade Name
- ECG Cable EUDAMED
- Device Name
- ECG cable EUDAMED
- Model / Reference
- DECG-IK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413816787 EUDAMED
- Basic UDI-DI
- 69444138ECGCableOWG EUDAMED
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES 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: Electrical-only medical device connection cable, reusable
ECG Cable by Edan Instruments, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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- ECG Cable — Edan Instruments,Inc. · Class I
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 | 69444138ECGCableOWG | Class I | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 800ffdb3-f960-4f7f-842c-f3c85f6dfd63 61 fields · synced May 21, 2026