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SMARTABLATE Irrigation Tubing Set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SAT001Model SMARTABLATE Irrigation Tubing Set
Identity
- Trade Name
- SMARTABLATE Irrigation Tubing Set EUDAMEDSMARTABLATE FDA UDI
- Generic Name
- Cardiac ablation system irrigation tubing set FDA UDI
- Device Name
- SMARTABLATE Irrigation Tubing Set EUDAMED
- Model / Reference
- SMARTABLATE Irrigation Tubing Set EUDAMEDSAT001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- SAT001 FDA UDI
- Primary DI / UDI-DI
- 10846835009743 EUDAMEDFDA UDI
- Basic UDI-DI
- 08468350a0005EX EUDAMED
- PMA Number
- P990071 FDA UDI
- FDA Product Code
- LPB FDA UDI
- EMDN Code
- Z12059080 VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cardiac ablation system irrigation tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass III FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
SMARTABLATE Irrigation Tubing Set by Biosense Webster Inc — Class IIa — 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 | 08468350a0005EX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 dbc506d0-325f-4d5a-9f0d-4b83f351d4cb 61 fields · synced Jun 18, 2026
- FDA UDI 87756afd-46ee-4af7-8a72-66a33b85daaf 36 fields · synced May 30, 2026