Identity
- Trade Name
- PATIENT CABLE SNAP 10 WIRES IEC FOR HD+ ORANGE FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Patient cable 10 wires for HD+ EUDAMEDPatient cable snap IEC cleared with HD+12 and HD+15 FDA UDI
- Model / Reference
- 63050104 EUDAMED63050104 rev. F FDA UDI
- Description
- Patient cable snap IEC cleared with HD+12 and HD+15 FDA UDI
Identifiers
- Catalog Number
- 63050104 FDA UDI
- Primary DI / UDI-DI
- 08056732652712 EUDAMEDFDA UDI
- Basic UDI-DI
- 0805673265022000015T EUDAMED
- Direct Marketing DI
- 08056732652712 EUDAMED
- FDA Product Code
- DRG FDA UDI
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2910 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
Yes
FDA UDI
Category: Electrocardiographic lead set, reusable
Patient cable 10 wires for HD+ by Cardioline Spa — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · 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 | 0805673265022000015T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (2)
- EUDAMED 2450b529-38b4-4e2e-86e9-264fdb5b5980 61 fields · synced Jun 18, 2026
- FDA UDI e34b2d0c-d5cd-4c69-83ad-6f8d6aaa2cce 36 fields · synced May 30, 2026