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ChainFor™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref PCR58, CFP58P25Model CFP58P50

EMDN W0105070501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08684595032442 Basic UDI-DIDate11 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08684595032442 Basic UDI-DIDate11 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 25 Oct 2026

Device Name
Mycoplasma genitalium qPCR Kit
Model / Reference
CFP58P50, PCR58, CFP58P25
Primary DI / UDI-DI
08684595032442, 08684595031964
Basic UDI-DI
B-08684595032442, 868499827PCR58Y8, B-08684595031964
EMDN Code
W0105070501 Stis / stds (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex na reagents
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 fc49934e-83f1-4e8a-bff8-eedf5e4dcc31 61 fields · synced 23 Oct 2026
  • EUDAMED 08684595032442|868499827PCR58Y8 61 fields · synced 24 Oct 2026
  • EUDAMED 08684595031964|868499827PCR58Y8 61 fields · synced 25 Oct 2026
  • EUDAMED 08684595031964|B-08684595031964 61 fields · synced 25 Oct 2026