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NeuroSpeed PTA Balloon Catheter

by Acandis GmbH EUDAMED

Active European Union

Ref 01-000630

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426065033NeuroSpeedNR Basic UDI-DIDate14 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000269464 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 0297
    Issued
    30 Oct 2025
    Expires
    31 Aug 2028
    Reason
    Change approved
  • 1000331236 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    6 Aug 2026
    Expires
    22 Mar 2028
    Reason
    Change approved

Specification

EUDAMED

Model / Reference
01-000630
Primary DI / UDI-DI
04260697381080
Direct Marketing DI
04260697381080
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006259

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