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AtriClip® PRO•V™ LAA Exclusion System

by AtriCure, Inc. 4 variants

Ref PROV50/A000974-7Model AtriClip ACH35

Active European Union

CE MDR

Valid until

12 Aug 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08401439000000000000016ZQ Basic UDI-DI 10840143910722UDI-DIDate23 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 754862 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    8 Apr 2026
    Expires
    12 Aug 2029
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
LAA Exclusion System
Model / Reference
AtriClip ACH35, PROV50/A000974-7
Primary DI / UDI-DI
10840143910722
Basic UDI-DI
08401439000000000000016ZQ
EMDN Code
P070404 Left atrial appendage occluders
Device Class
Class III
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

  • Sterile
  • Implantable
  • CMR Substance

Other properties (10)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No