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Farastar™

by Farapulse Inc 8 variants

Ref M004PFCE61M400

Farastar (M004PFCE61M400) is a medical device (EU MDR Class IIb; EMDN category cardiac tissue ablation devices) made by Farapulse Inc, registered in EUDAMED on 18 Mar 2026 (Basic UDI-DI 081008718FARAGYE), active as of 24 Oct 2026.

Active European Union

CE MDR

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 Number081008718FARAGYE Basic UDI-DI 00810087181314UDI-DIDate18 Mar 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
FARAPULSE PFA Capital Equipment
Model / reference
M004PFCE61M400
Primary DI / UDI-DI
00810087181314
Basic UDI-DI
081008718FARAGYE
EMDN code
C020399 Cardiac tissue ablation devices - other
Device class
Class IIb
EU registration type
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)