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CARTO 3 System Interface cable
EUDAMEDFDA UDIClass I (EU MDR)
Ref D129707Model CARTO 3 System Interface Cables
Identity
- Trade Name
- CARTO 3 System Interface cable EUDAMEDCarto 3 FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- CARTO 3 System Interface Cables EUDAMED
- Model / Reference
- CARTO 3 System Interface Cables EUDAMEDD129707 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- D129707 FDA UDI
- Primary DI / UDI-DI
- 10846835009439 EUDAMEDFDA UDI
- Basic UDI-DI
- 08468350a0004EV EUDAMED
- Direct Marketing DI
- 10846835009439 EUDAMED
- 510(k) Number
- K090017 FDA UDI
- FDA Product Code
- DQK 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 II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Market of Registration
- Belgium 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
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 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 | 08468350a0004EV | 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 a7eb969c-6e14-48db-8b3c-ca224a093158 61 fields · synced Jun 18, 2026
- FDA UDI 7c4ee1ab-19b8-4220-b5e6-371cc4213562 36 fields · synced May 30, 2026