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CARTO 3 System eco Interface Cable
EUDAMEDFDA UDIClass I (EU MDR)
Ref D134401Model 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 CatheterRef FG540000UModel CARTO 3 System
Identity
- Trade Name
- CARTO 3 System eco Interface Cable EUDAMEDCARTO 3 SYSTEM EUDAMEDCarto 3 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 EUDAMEDCARTO 3 System 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 EUDAMEDD134401 EUDAMEDFDA UDICARTO 3 System EUDAMEDFG540000U EUDAMED
Identifiers
- Catalog Number
- D134401 FDA UDI
- Primary DI / UDI-DI
- 10846835009712 EUDAMEDFDA UDI10846835015669 EUDAMED
- Basic UDI-DI
- 08468350a0003ET EUDAMED08468350a0024F3 EUDAMED
- Direct Marketing DI
- 10846835009712 EUDAMED10846835015669 EUDAMED
- 510(k) Number
- K113213 FDA UDI
- FDA Product Code
- DRF FDA UDI
- EMDN Code
- Z12059080 VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES EUDAMEDZ12059002 CARDIAC MAPPING EQUIPMENT EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1220 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMED
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
EUDAMEDEUDAMED
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
CARTO 3 System eco 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 (3)
- EUDAMED c6277fd1-ab4d-4106-b021-2d25b4512f55 61 fields · synced Jul 10, 2026
- FDA UDI 82bf10a0-9f41-4042-8fe5-89f3ad1aa780 36 fields · synced May 30, 2026
- EUDAMED f07bf06c-2ea5-438b-885b-32fcfc68b8d8 61 fields · synced Jul 10, 2026