Identity
- Trade Name
- Disposable ECG Lead Wire EUDAMED
- Device Name
- Disposable ECG Lead Wires EUDAMED
- Model / Reference
- 2585DP-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936735497348 EUDAMED
- Basic UDI-DI
- 69456648DEC1VD EUDAMED
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - CONSUMABLES 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: Electrocardiographic lead set, reusable
Disposable ECG Lead Wire by Unimed Medical Supplies, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
- Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- AMC — Advantage Medical Electronics, LLC · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Multi-Link™ X2 Single-Patient-Use Direct-Connect Telemetry ECG Leadwire Set 3-Lead Set for Mindray, Snap, IEC — AirLife Finland Oy · Class I
- Multi-LinkTM X2 Single-Patient-Use Long ECG Leadwire Set 6-Lead Set, Grabber, IEC, 3.6 m/12 ft — AirLife Finland Oy · Class I
- APK — Apk Technology · Class II
- AMC — Advantage Medical Electronics, LLC · 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 | 69456648DEC1VD | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unimed Medical Supplies, Inc
- EUDAMED SRN
- CN-MF-000001480
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED d5824c8e-0af6-4c76-8cf9-6b9e04c263b1 61 fields · synced Jun 19, 2026