Identity
- Trade Name
- FARAWAVE™ EUDAMED
- Device Name
- FARAWAVE Pulsed Field Ablation Catheter, 31mm EUDAMEDFARAWAVE Pulsed Field Ablation Catheter, 35mm EUDAMED
- Model / Reference
- 41M401 EUDAMED41M402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810087180096 EUDAMED00810087180102 EUDAMED
- Basic UDI-DI
- B-00810087180096 EUDAMEDB-00810087180102 EUDAMED
- EMDN Code
- C020304 ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Farawave™ by Farapulse 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-00810087180096 | Class III | Active |
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Manufacturer
- Manufacturer
- Farapulse Inc
- EUDAMED SRN
- US-MF-000017969
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED 9f30fbac-203d-47fd-9bdf-bed647ff2fa4 61 fields · synced Jul 23, 2026
- EUDAMED a637949e-913e-4f51-92d6-8a72c21bbfd0 61 fields · synced May 18, 2026