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ChainFor™

by Vitrosens Biotechnology Inc. Türkiye EUDAMED

Ref PCR43Model CFP43P100 EMDN W0105020507

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08683548257703 Basic UDI-DIDate6 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  • Withdrawn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 24 Oct 2026

Device Name
HEV qPCR Kit
Model / Reference
CFP43P100, PCR43
Primary DI / UDI-DI
08683548257703
Basic UDI-DI
B-08683548257703, 868511580PCR43JC
EMDN Code
W0105020507 Hepatitis e virus - 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 (2)

  • EUDAMED a6be8530-c7ef-4a14-b86c-8528386682c4 61 fields · synced 24 Oct 2026
  • EUDAMED 08683548257703|868511580PCR43JC 61 fields · synced 9 Oct 2026