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RapidFor™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref VMD04, VMD04BD50Model VMD04BD50LA

EMDN W0105090105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08684998272179 Basic UDI-DIDate26 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08684998272179 Basic UDI-DIDate26 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Syphilis Ab Test Kit
Model / Reference
VMD04BD50LA, VMD04, VMD04BD50
Primary DI / UDI-DI
08684998272179, 08684595036600
Basic UDI-DI
B-08684998272179, 868334794VMD04BDZM, B-08684595036600
EMDN Code
W0105090105 Syphilis - 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 (4)

  • EUDAMED e7f08467-ee60-4c25-935c-9cd29300b167 61 fields · synced 23 Oct 2026
  • EUDAMED 08684595036600|868334794VMD04BDZM 61 fields · synced 24 Oct 2026
  • EUDAMED 08684595036600|B-08684595036600 61 fields · synced 24 Oct 2026
  • EUDAMED 08684998272179|868334794VMD04BDZM 61 fields · synced 24 Oct 2026