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Ultraflex™

by Boston Scientific Corporation United States EUDAMED

Ref M00564590

EMDN P0401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number01915060000000000000122MF Basic UDI-DIDate5 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3827895TD02 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    22 Mar 2023
    Expires
    22 Mar 2028

Specification

EUDAMED · synced 24 Oct 2026

Device Name
UltraflexTM Tracheobronchial
Model / Reference
M00564590
Primary DI / UDI-DI
08714729645900
Basic UDI-DI
01915060000000000000122MF
EMDN Code
P0401 Tracheobronchial prostheses
Device Class
Class IIb
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
  • Implantable
Other properties (13)
  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: 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 08714729645900|01915060000000000000122MF 61 fields · synced 24 Oct 2026