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SMARTABLATE System Interface Cable
EUDAMEDFDA UDIClass I (EU MDR)
Ref D130303Model SMARTABLATE System Interface Cable Stockert and CARTO XP Interface Cables CARTO 3 System Interface Cables Interface Cables CARTO 3 SYSTEM eco Interface Cable TX eco EXT Cable Interface Cables for Multi-Electrode Ablation Catheter and CELSIUS Catheter
Identity
- Trade Name
- SMARTABLATE System Interface Cable EUDAMEDSMARTABLATE FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- SMARTABLATE System Interface Cable Stockert and CARTO XP Interface Cables CARTO 3 System Interface Cables Interface Cables CARTO 3 SYSTEM eco Interface Cable TX eco EXT Cable Interface Cables for Multi-Electrode Ablation Catheter and CELSIUS Catheter EUDAMED
- Model / Reference
- SMARTABLATE System Interface Cable Stockert and CARTO XP Interface Cables CARTO 3 System Interface Cables Interface Cables CARTO 3 SYSTEM eco Interface Cable TX eco EXT Cable Interface Cables for Multi-Electrode Ablation Catheter and CELSIUS Catheter EUDAMEDD130303 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- D130303 FDA UDI
- Primary DI / UDI-DI
- 10846835012644 EUDAMEDFDA UDI
- Basic UDI-DI
- 08468350a0003ET EUDAMED
- Direct Marketing DI
- 10846835012644 EUDAMED
- PMA Number
- P990071 FDA UDI
- FDA Product Code
- LPB FDA UDI
- EMDN Code
- Z12059080 VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
SMARTABLATE System Interface Cable by Biosense Webster Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 08468350a0003ET | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biosense Webster, Inc
- EUDAMED SRN
- US-MF-000014219
- Authorised Representative
- Biosense Webster A Division of Johnson & Johnson Medical NV/SA BE-AR-000012231
Sources (2)
- EUDAMED 3dce55d2-1ddd-4fda-83b9-14b75c8eaa4e 61 fields · synced Jul 10, 2026
- FDA UDI 5478ad27-691e-4a5e-8eb8-8cf32a4b7bd9 36 fields · synced May 30, 2026