Identity
- Trade Name
- FARASTAR EUDAMED
- Device Name
- FARASTAR Pulsed Field Ablation Generator EUDAMEDFARAPULSE PFA Capital Equipment EUDAMED
- Model / Reference
- 61M401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810087180126 EUDAMED
- Basic UDI-DI
- B-00810087180126 EUDAMED081008718FARAGYE EUDAMED
- EMDN Code
- Z120101 ARTERIOTOMY ABLATORS EUDAMEDC020399 CARDIAC TISSUE ABLATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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 IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00810087180126 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00810087180126 | Class IIb | 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 cd7d40e1-80c6-4026-8299-5604a7c42ab9 61 fields · synced Jul 12, 2026
- EUDAMED 4047a704-3ca2-4e66-936b-d7c06eb84ac9 61 fields · synced May 19, 2026