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Farawave™

by Farapulse Inc

Ref 41M401, 41M402

Farawave (41M401) is a medical device (EU MDD Class III; EMDN category arrhythmogenic foci pulsed field ablation catheters) made by Farapulse Inc, registered in EUDAMED on 19 Mar 2026 (Basic UDI-DI B-00810087180096), active as of 24 Oct 2026.

Active European Union

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/MDD NumberB-00810087180096 Basic UDI-DI Date19 Mar 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
FARAWAVE Pulsed Field Ablation Catheter, 31mm
FARAWAVE Pulsed Field Ablation Catheter, 35mm
Model / reference
41M401, 41M402
Primary DI / UDI-DI
00810087180096, 00810087180102
Basic UDI-DI
B-00810087180096, B-00810087180102
EMDN code
C020304 Arrhythmogenic foci pulsed field ablation catheters
Device class
Class III
EU registration type
Legacy device (under a directive)
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 devices from Farapulse Inc

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Properties

  • Supplied sterile
  • Contains animal tissues or cells
Other properties (12, all answered No)