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Farastar™

by Farapulse Inc 8 variants

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

Ref 61M404

Farastar (61M404) 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-00810087180171), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-00810087180171 Basic UDI-DI 00810087180171UDI-DIDate19 Mar 2026RegisteredStatusActive
European UnionCE/MDD NumberB-00810087180171 Basic UDI-DI 00810087180171UDI-DIDate19 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  • Withdrawn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 Stimulation Module Cable
FARAPULSE PFA Capital Equipment Components
Model / reference
61M404
Primary DI / UDI-DI
00810087180171
Basic UDI-DI
B-00810087180171, 081008718CABLEVS
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

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Properties

Other properties (14, all answered No)