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REFSTAR with QWIKPATCH External Reference Patch
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 34N01MModel CARTO 3 System External Reference Patches REFSTAR with QWIKPATCH REFSTAR PLUS with QWIKPATCH
Identity
- Trade Name
- REFSTAR with QWIKPATCH External Reference Patch EUDAMEDRefStar QwikPatch 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 EUDAMED34N01M EUDAMEDXRP6H FDA UDI
Identifiers
- Catalog Number
- XRP6H FDA UDI
- Primary DI / UDI-DI
- 10846835000665 EUDAMEDFDA UDI
- Basic UDI-DI
- 08468350a0001EP EUDAMED
- FDA Product Code
- DRF FDA UDI
- EMDN Code
- C020105 NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS 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
- Commercial Distribution
- Not 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
REFSTAR with QWIKPATCH External Reference Patch by Biosense Webster Inc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K061468 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 08468350a0001EP | Class I | Active |
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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 0454a0ea-9e13-432d-8ac5-e77c3458749c 61 fields · synced Jul 18, 2026
- FDA UDI cdd9bce1-f69b-4403-8b76-8e33f64e14a5 36 fields · synced May 30, 2026
- FDA 510(k) K061468 1 fields · synced May 18, 2026