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CARTO 3 System External Reference Patches
EUDAMEDFDA UDIClass I (EU MDR)
Ref CREFP6Model CARTO 3 System External Reference Patches REFSTAR with QWIKPATCH REFSTAR PLUS with QWIKPATCH
Identity
- Trade Name
- CARTO 3 System External Reference Patches EUDAMEDReference Patch CARTO 3 FDA UDI
- Generic Name
- Cardiac mapping system reference patch FDA UDI
- Device Name
- CARTO 3 System/ REFSTAR with QWIKPATCH/ REFSTAR PLUS with QWIKPATCH External Reference Patch EUDAMED
- Model / Reference
- CARTO 3 System External Reference Patches REFSTAR with QWIKPATCH REFSTAR PLUS with QWIKPATCH EUDAMEDCREFP6 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- CREFP6 FDA UDI
- Primary DI / UDI-DI
- 20846835000129 EUDAMEDFDA UDI
- Basic UDI-DI
- 08468350a0001EP EUDAMED
- FDA Product Code
- DRF FDA UDI
- EMDN Code
- C0280 ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Cardiac mapping system reference patch FDA UDI
Classification
- Device Class
- Class I 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
No
EUDAMEDFDA UDI
Single Use
Yes
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 External Reference Patches 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 | 08468350a0001EP | 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 2f330ac5-6322-45b7-b0b3-8891eeda27e3 61 fields · synced May 30, 2026
- FDA UDI ea42ef0d-3088-4924-8098-304a004d7160 35 fields · synced May 30, 2026