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Watchman Flx™

by Boston Scientific Corporation United States EUDAMED

Ref M635WS60400

EMDN P070404

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01915060000000000000569NV Basic UDI-DIDate6 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 813080 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    11 Sep 2026
    Expires
    17 Jun 2030
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Device Name
WATCHMAN FLX Pro
Model / Reference
M635WS60400
Primary DI / UDI-DI
00191506004699
Basic UDI-DI
01915060000000000000569NV
EMDN Code
P070404 Left atrial appendage occluders
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000004702
Authorised representative
Boston Scientific Limited IE-AR-000003840

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 00191506004699|01915060000000000000569NV 61 fields · synced 24 Oct 2026