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Carto 3 System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref FG540000Model CARTO 3 System
Identity
- Trade Name
- CARTO 3 SYSTEM EUDAMEDCARTO 3 FDA UDI
- Generic Name
- Cardiac mapping system FDA UDI
- Device Name
- CARTO 3 System EUDAMEDFDA UDI
- Model / Reference
- CARTO 3 System EUDAMEDFG540000 EUDAMEDFDA UDI
- Description
- CARTO 3 System FDA UDI
Identifiers
- Catalog Number
- FG-5400-00 FDA UDI
- Primary DI / UDI-DI
- 10846835000870 EUDAMEDFDA UDI
- Basic UDI-DI
- 08468350a0002ER EUDAMED
- 510(k) Number
- K072202 FDA UDIK090017 FDA UDIK170600 FDA UDIK173977 FDA UDIK173978 FDA UDIK180238 FDA UDIK191660 FDA UDIK200484 FDA UDIK213264 FDA UDIK221112 FDA UDIK223733 FDA UDIK231207 FDA UDI
- FDA Product Code
- DQK FDA UDI
- EMDN Code
- Z12059002 CARDIAC MAPPING EQUIPMENT EUDAMED
- GMDN Term
- Cardiac mapping system FDA UDI
Classification
- Device Class
- Class IIa 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Carto 3 System by Biosense Webster (israel) Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954395 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08468350a0002ER | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biosense Webster (Israel) Ltd.
- EUDAMED SRN
- IL-MF-000017055
- Authorised Representative
- Biosense Webster A Division of Johnson & Johnson Medical NV/SA BE-AR-000012231
Sources (3)
- EUDAMED bdef7fb0-2aba-408c-b4a3-5595eaf721c8 61 fields · synced Jul 12, 2026
- FDA UDI 2ff777cb-fdda-4ea4-8816-0ee1048417b3 36 fields · synced May 30, 2026
- FDA 510(k) K954395 1 fields · synced May 18, 2026