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Isolator Surgical Ablation System

by AtriCure, Inc.

Ref A001360Model FSW2

Isolator Surgical Ablation System (A001360) is a Class I device made by Atricure, Inc., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 08401439000000000000022ZK), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08401439000000000000022ZK Basic UDI-DI 30840143904350UDI-DIDate23 Jun 2026RegisteredStatusActive

Official records

  • EUDAMED public site Basic UDI-DI 08401439000000000000022ZK — open Devices and search for it

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
RF Footswitch
Model / reference
FSW2, A001360
Primary DI / UDI-DI
30840143904350
Basic UDI-DI
08401439000000000000022ZK
Direct marketing DI
10840143904806
EMDN code
Z12059011 Cardiac ablation equipment
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000002974
Authorised representative
AtriCure Europe B.V. NL-AR-000000165

Other devices from Atricure, Inc.

See all devices from Atricure, Inc. →

Properties

  • Sterilise before use
  • Reusable
Other properties (12, all answered No)