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RapidFor™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref VMD35Model VMD35D EMDN W0105090102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08683347941421 Basic UDI-DIDate26 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
H.Pylori Ab Test Kit
Model / Reference
VMD35D, VMD35
Primary DI / UDI-DI
08683347941421
Basic UDI-DI
B-08683347941421, 868459503VMD35DTN
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class IVD General
Class C
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 5b0cd371-9b45-498e-86bf-4a9f3513f044 61 fields · synced 25 Oct 2026
  • EUDAMED 08683347941421|868459503VMD35DTN 61 fields · synced 24 Oct 2026