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U-Prevent

by Ortec B.V. EUDAMED

Active European Union

Ref U-Prevent

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberP000535115CRT01 Date15 Jun 2026IssuedStatusActive expires 15 Jun 2031
European UnionCE/MDD Number0152886U-PreventEE Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • P000535115CRT01 Issued

    Quality management system EU MDR

    Notified body
    Notified body 1912
    Issued
    15 Jun 2026
    Expires
    15 Jun 2031

Specification

EUDAMED

Device Name
U-Prevent
Model / Reference
U-Prevent
Primary DI / UDI-DI
08720892217912
Basic UDI-DI
0152886U-PreventEE, B-08720892217912
Direct Marketing DI
08720892217912
EMDN Code
Z129092 Various instruments for functional exploration and therapeutic interventions - medical device software
Device Class
Class IIa
Class I
Special Device Type
Software
-1192
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000036789

Other devices from Ortec B.V.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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