Identity
- Trade Name
- FARASTAR EUDAMED
- Device Name
- FARASTAR Catheter Connection Cable EUDAMED
- Model / Reference
- 41M404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810087180119 EUDAMED
- Basic UDI-DI
- B-00810087180119 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
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Farastar 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-00810087180119 | 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 (1)
- EUDAMED 8fa7cf7d-3dd1-44bf-a1f4-099c9bd76560 61 fields · synced Jun 18, 2026