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Farastar

by Farapulse Inc 2 variants

Ref 61M407

Farastar (61M407) is a medical device (EU MDR Class IIb) made by Farapulse Inc, registered in EUDAMED on 19 Mar 2026 (Basic UDI-DI B-00810087180133), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-00810087180133 Basic UDI-DI 00810087180133UDI-DIDate19 Mar 2026RegisteredStatusActive
European UnionCE/MDD NumberB-00810087180133 Basic UDI-DI 00810087180133UDI-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  • Withdrawn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 Recording System Module
FARAPULSE PFA Capital Equipment
Model / reference
61M407
Primary DI / UDI-DI
00810087180133
Basic UDI-DI
B-00810087180133, 081008718FARAGYE
EMDN code
Z120101, C020399
Device class
Class IIb
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)