Skip to content

Farastar™

by Farapulse Inc 8 variants

Part of a family of 7 devices: see the family page

Ref 61M415, 61M412, 61M413, 61M416, M004PFCE61M500

Farastar (61M415) is a medical device (EU MDR Class IIb; EU MDR Class I) made by Farapulse Inc, registered in EUDAMED on 19 Mar 2026 (Basic UDI-DI B-00810087180263), active as of 25 Oct 2026.

Active European Union

CE MDR CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-00810087180263 Basic UDI-DI Date19 Mar 2026RegisteredStatusActive
European UnionCE/MDD NumberB-00810087180263 Basic UDI-DI Date19 Mar 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device name
FARASTAR Recording System Module ECG Trunk Cable
FARASTAR Stimulation Module Y-Cable Short
FARASTAR Recording System Module Catheter Pin Cable
FARASTAR Recording System Module ECG Output Module
FARAPULSE PFA Capital Equipment Components
FARAPULSE PFA Capital Equipment
Model / reference
61M415, 61M412, 61M413, 61M416, M004PFCE61M500
Primary DI / UDI-DI
00810087180263, 00810087180249, 00810087180256, 00810087180270, 00810087181321
Basic UDI-DI
B-00810087180263, B-00810087180249, B-00810087180256, B-00810087180270, 081008718CABLEVS, 081008718FARAGYE
EMDN code
Z120101, C020399
Device class
Class IIb
Class I
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000017969
Authorised representative
ICON (LR) Limited IE-AR-000006507

Similar devices in this category

Other devices filed under CARDIAC TISSUE ABLATION DEVICES - OTHER.

Other devices from Farapulse Inc

See all devices from Farapulse Inc →

Properties

Other properties (14, all answered No)