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Farastar™
EUDAMEDClass IIb (EU MDR)
Ref 61M415Ref 61M412Ref 61M413Ref 61M416Ref M004PFCE61M500
Identity
- Trade Name
- FARASTAR™ EUDAMED
- Device Name
- FARASTAR Recording System Module ECG Trunk Cable EUDAMEDFARASTAR Stimulation Module Y-Cable Short EUDAMEDFARASTAR Recording System Module Catheter Pin Cable EUDAMEDFARASTAR Recording System Module ECG Output Module EUDAMEDFARAPULSE PFA Capital Equipment Components EUDAMEDFARAPULSE PFA Capital Equipment EUDAMED
- Model / Reference
- 61M415 EUDAMED61M412 EUDAMED61M413 EUDAMED61M416 EUDAMEDM004PFCE61M500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810087180263 EUDAMED00810087180249 EUDAMED00810087180256 EUDAMED00810087180270 EUDAMED00810087181321 EUDAMED
- Basic UDI-DI
- B-00810087180263 EUDAMEDB-00810087180249 EUDAMEDB-00810087180256 EUDAMEDB-00810087180270 EUDAMED081008718CABLEVS EUDAMED081008718FARAGYE 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-00810087180263 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00810087180263 | 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 (7)
- EUDAMED 55411f8a-96ae-4b5b-ab04-b44628074606 61 fields · synced Aug 2, 2026
- EUDAMED fb646ddc-dcd9-4ef0-9831-d8b3e928879f 61 fields · synced May 18, 2026
- EUDAMED 9e2a4f42-e7e9-47c4-ac78-e3f93d7d2abf 61 fields · synced May 18, 2026
- EUDAMED 527c4131-2b60-48da-aca2-f0fa3c009977 61 fields · synced May 19, 2026
- EUDAMED cfdbd368-5cbc-4695-8557-9495aac5efaf 61 fields · synced Jul 9, 2026
- EUDAMED c1361088-a140-43f1-93bf-07c385aaa4d2 61 fields · synced Jul 28, 2026
- EUDAMED 61461f21-e0bc-495b-bd26-04c77c58c2a3 61 fields · synced Jul 28, 2026