Skip to content

ChainFor™

by Vitrosens Biotechnology Inc. 132 variants

Ref PCR111, LYO01Model CFP111P50

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08683548259202 Basic UDI-DI Date17 Aug 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08683548259202 Basic UDI-DI Date17 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Trade Name
ChainFor™
LyoSens SARS-CoV-2 & Flu A/B Detection qPCR Kit
Device Name
Strep B qPCR Kit
SARS-CoV-2 & Flu A/B Detection qPCR Kit
Model / Reference
CFP111P50, PCR111, LYO01
Primary DI / UDI-DI
08683548259202, 08683548258410
Basic UDI-DI
B-08683548259202, B-08683548258410, 868511580PCR111G8
EMDN Code
W0105011104, W0105040504, W0105040519
Device Class
Class IVD General
Class C
EU market of registration
Türkiye
Germany

Manufacturer details

EUDAMED SRN
TR-MF-000026452

Other devices from Vitrosens Biotechnology Inc.

See all devices from Vitrosens Biotechnology Inc. →

Properties

  • Reagent
  • Near-Patient Testing NoEUDAMEDYesEUDAMED
  • Professional Testing
  • Companion Diagnostics NoEUDAMEDYesEUDAMED
  • Surgical Instrument NoEUDAMEDYesEUDAMED

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • New Device: No