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ChainFor™

by Vitrosens Biotechnology Inc. 5 variants

Ref CFP34P25, CFP34P50, PCR34

ChainFor™ (CFP34P25) is a device classified as Class B (EU), IVD General (EU) made by Vitrosens Biotechnology Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 868354825PCR34NS), active as of 7 Nov 2026.

Active European Union

CE IVDR CE IVDD

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number868354825PCR34NS Basic UDI-DI Date2 Nov 2026RegisteredStatusActive
European UnionCE/IVDR Number868354825PCR34NS Basic UDI-DI Date2 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Device name
Mycoplasma pneumoniae qPCR Kit
Model / reference
CFP34P25, CFP34P50, PCR34
Primary DI / UDI-DI
08684595031704, 08684595033364
Basic UDI-DI
868354825PCR34NS, B-08684595033364, B-08684595031704
EMDN code
W010501080301 Mycoplasma pneumoniae detection by na reagents
Device class
Class B
Class IVD General
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000026452

Similar devices in this category

Other devices filed under MYCOPLASMA / UREAPLASMA DETECTION BY NA REAGENTS.

Other devices from Vitrosens Biotechnology Inc.

See all devices from Vitrosens Biotechnology Inc. →

Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (10, all answered No)