Identity
- Trade Name
- FARASTAR™ EUDAMED
- Device Name
- FARASTAR Recording System Module EGM Input Module EUDAMEDFARAPULSE PFA Capital Equipment Components EUDAMED
- Model / Reference
- 61M417 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810087180287 EUDAMED
- Basic UDI-DI
- B-00810087180287 EUDAMED081008718CABLEVS EUDAMED
- EMDN Code
- Z120101 ARTERIOTOMY ABLATORS EUDAMEDC020399 CARDIAC TISSUE ABLATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I 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-00810087180287 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00810087180287 | 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 85ebd61f-44e9-4a0a-8fcc-4196668b4dfd 61 fields · synced Sep 17, 2026
- EUDAMED 51484e3d-1330-4524-b73f-da8166da7609 61 fields · synced Jun 18, 2026