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Preventis SmarTest® Calprotectin Home

by Immundiagnostik AG EUDAMED

Active European Union

Ref PST11001EP01

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4050598LFSTCalhoZ4 Basic UDI-DIDate5 Aug 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 788157 Amended

    Technical documentation EU IVDR

    Notified body
    Notified body 2797
    Issued
    8 Dec 2025
    Expires
    14 Jul 2030
    Reason
    Other

Specification

EUDAMED

Model / Reference
PST11001EP01
Primary DI / UDI-DI
04050598008717
Basic UDI-DI
4050598LFSTCalhoZ4
Direct Marketing DI
04050598008717
EMDN Code
W0102019009 Calprotectin
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000020905

Other devices from Immundiagnostik AG

See all devices from Immundiagnostik AG →

Properties

Show properties
  • Self Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No