Identity
- Trade Name
- FARASTAR EUDAMED
- Device Name
- FARASTAR Recording System Module EUDAMEDFARAPULSE PFA Capital Equipment EUDAMED
- Model / Reference
- 61M407 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810087180133 EUDAMED
- Basic UDI-DI
- B-00810087180133 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-00810087180133 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00810087180133 | 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 01aa139c-8770-4b32-ae8a-bc09cb0fb2a0 61 fields · synced Jul 26, 2026
- EUDAMED fb700fcf-9c51-496b-a76f-78781fed4c0c 61 fields · synced Jul 13, 2026