ECG Cable with Lead wires
EUDAMEDClass I (EU MDR)
Identity
- Trade Name
- ECG Cable with Lead wires EUDAMED
- Device Name
- ECG cables with lead wires EUDAMED
- Model / Reference
- AMD-EG-FC0037-I EUDAMEDAMD-EC-VA0006-R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931377220958 EUDAMED
- Basic UDI-DI
- 69313772808UY EUDAMED
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
No
Incorporates Medicinal Product
No
Category: General-purpose multi-parameter bedside monitor
Our ECG cable with lead wires device is a Class I medical device designed for use in various medical settings. It features multiple components, including an electrode and a lead wire, ensuring accurate and reliable electrocardiogram readings. With its comprehensive set of specifications and certifications, this device is suitable for a wide range of applications.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69313772808UY | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Amydi-med Electrics Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000013201
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED bb48f13c-1685-4fbe-bd7b-68dd5a8ddabc 61 fields · synced Jun 28, 2026