Patient cable 10 wires for HD+
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- PATIENT CABLE PLUG 10 WIRES AHA FOR HD+ ORANGE FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Patient cable 10 wires for HD+ EUDAMEDPatient cable plug AHA cleared with HD+12 and HD+15 FDA UDI
- Model / Reference
- 63050156 EUDAMED63050148 EUDAMED63050154 EUDAMED63050106 EUDAMED63050150 EUDAMED63050164 EUDAMED63050157 EUDAMED63050105 EUDAMED63050106 rev. F FDA UDI
- Description
- Patient cable plug AHA cleared with HD+12 and HD+15 FDA UDI
Identifiers
- Catalog Number
- 63050106 FDA UDI
- Primary DI / UDI-DI
- 08056732653320 EUDAMED08056732653092 EUDAMED08056732653306 EUDAMED08056732652736 EUDAMEDFDA UDI08056732653115 EUDAMED08056732653467 EUDAMED08056732653337 EUDAMED08056732652729 EUDAMED
- Basic UDI-DI
- 0805673265022000015T EUDAMED
- Direct Marketing DI
- 08056732653320 EUDAMED08056732653092 EUDAMED08056732653306 EUDAMED08056732652736 EUDAMED08056732653115 EUDAMED08056732653467 EUDAMED08056732653337 EUDAMED08056732652729 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
Single Use
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
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
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 (9)
- EUDAMED 98e9ce65-f749-4031-8a5b-bf3f0028c158 61 fields · synced Aug 2, 2026
- EUDAMED 78455ff1-f10d-4e0f-80bd-dc627a65ae2d 61 fields · synced May 18, 2026
- EUDAMED 917732d1-8cfe-4ae0-96ac-2ddb85c09f7d 61 fields · synced May 18, 2026
- EUDAMED dc8f8feb-3e55-411a-ad36-e4d6f7a88e80 61 fields · synced May 18, 2026
- EUDAMED 0a5cabfe-d1fa-4cfc-a0c0-cf98a91cae48 61 fields · synced May 18, 2026
- EUDAMED bc2e0401-aaf8-45a3-92ad-bbed2a90453e 61 fields · synced May 18, 2026
- EUDAMED 0c1ca404-60c0-4e80-974c-f135c6af1dd1 61 fields · synced May 18, 2026
- EUDAMED d2f82fe9-d060-426d-b285-f3c36da2b22f 61 fields · synced May 19, 2026
- FDA UDI 78f493aa-c21f-4b1c-886e-becb90de4dea 36 fields · synced May 30, 2026