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ChainFor™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref PCR127, CFP127P100Model CFP127P25, CFP127P50

EMDN W0105040599

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08685115804693 Basic UDI-DIDate31 Jul 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08685115804693 Basic UDI-DIDate31 Jul 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
NiPV qPCR Kit
Model / Reference
CFP127P25, PCR127, CFP127P50, CFP127P100
Primary DI / UDI-DI
08685115804693, 08685115804709, 08685115804716
Basic UDI-DI
B-08685115804693, B-08685115804709, 868511580PCR127GP, B-08685115804716
EMDN Code
W0105040599 Virology - na reagents - other
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 (5)

  • EUDAMED c4fe9d3a-fc47-45c8-80d3-0747bb4ee688 61 fields · synced 23 Oct 2026
  • EUDAMED 08685115804709|B-08685115804709 61 fields · synced 12 Oct 2026
  • EUDAMED 08685115804716|868511580PCR127GP 61 fields · synced 24 Oct 2026
  • EUDAMED 08685115804716|B-08685115804716 61 fields · synced 24 Oct 2026
  • EUDAMED 08685115804709|868511580PCR127GP 61 fields · synced 24 Oct 2026