Identity
- Trade Name
- One-piece EKG Diagnosis Cable EUDAMEDUnimed FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- ECG Cables & Lead Wires EUDAMEDOne piece EKG Diagnosis Cable/Schiller long screw/10-lead/4mm banana/IEC/2.2M+1.2M*4+0.8M*6/070 FDA UDI
- Model / Reference
- E10R-SH1-B/I EUDAMEDFDA UDI
- Description
- One piece EKG Diagnosis Cable/Schiller long screw/10-lead/4mm banana/IEC/2.2M+1.2M*4+0.8M*6/070 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945664848046 EUDAMEDFDA UDI
- Basic UDI-DI
- 69456648REC1YF EUDAMED
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - CONSUMABLES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic lead set, reusable
One-piece EKG Diagnosis Cable by Unimed Medical Supplies, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69456648REC1YF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Unimed Medical Supplies, Inc
- EUDAMED SRN
- CN-MF-000001480
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED f20e1d69-8beb-4e83-90f3-9fe6b61b485e 61 fields · synced Jun 19, 2026
- FDA UDI f3c5821e-22ac-4e53-84af-463f8ef28e6f 33 fields · synced May 30, 2026