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Afias Pct X

by Boditech Med Inc. EUDAMED

Active European Union

Ref SMFP-119Model AFIAS PCT X

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number880613300613CA Basic UDI-DIDate29 Jun 2026RegisteredStatusActive
European UnionCE/IVDR Number880613300613CA Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
AFIAS PCT X, SMFP-119
Primary DI / UDI-DI
08806133044506, 08806133006139
Basic UDI-DI
880613300613CA, B-08806133006139
EMDN Code
W0102069013 Procalcitonin
Device Class
Class C
Class IVD General
Market of Registration
Germany
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000011028
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

Show properties
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No