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RapidFor™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref VMPO87ED, VMPO87

EMDN W0102160703

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number868354825VMPO87PPRQ Basic UDI-DIDate28 Aug 2026RegisteredStatusActive
European UnionCE/IVDR Number868354825VMPO87PPRQ Basic UDI-DIDate28 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
hs-cTnI (FIA)
Model / Reference
VMPO87ED, VMPO87
Primary DI / UDI-DI
08685115801876
Basic UDI-DI
868354825VMPO87PPRQ, B-08685115801876
EMDN Code
W0102160703 Troponin i/t - rt & poc
Device Class
Class C
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026452

Other devices from Vitrosens Biotechnology Inc.

See all devices from Vitrosens Biotechnology Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 08685115801876|868354825VMPO87PPRQ 61 fields · synced 24 Oct 2026
  • EUDAMED 08685115801876|B-08685115801876 61 fields · synced 24 Oct 2026