← Back to catalogue
Avail Electrophysiology Catheter
EUDAMEDClass III (EU MDR)
Ref 37C3FRRef 37C5RRRef 37D5CRRef 37P0RR
Identity
- Trade Name
- AVAIL ELECTROPHYSIOLOGY CATHETER EUDAMED
- Model / Reference
- 37C3FR EUDAMED37C5RR EUDAMED37D5CR EUDAMED37P0RR EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF000014219000009QN EUDAMEDD-USMF000014219000008QL EUDAMEDD-USMF000014219000014QF EUDAMEDD-USMF000014219000012QB EUDAMED
- Basic UDI-DI
- B-USMF000014219000009QN EUDAMEDB-USMF000014219000008QL EUDAMEDB-USMF000014219000014QF EUDAMEDB-USMF000014219000012QB EUDAMED
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Avail Electrophysiology Catheter by Biosense Webster Inc — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000014219000009QN | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
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 (4)
- EUDAMED b0b1e161-e09d-4d01-8352-cf2f1be94c62 61 fields · synced Jul 26, 2026
- EUDAMED 71bdcc44-9f92-4a15-ac46-2f19c0bca14f 61 fields · synced May 17, 2026
- EUDAMED 02778991-7cd7-4169-ba8f-95ad25fe7b94 61 fields · synced May 18, 2026
- EUDAMED 10d85b57-c8c5-4caa-a9c5-ddabeac6e5d1 61 fields · synced May 18, 2026