Skip to content

Fluorescence lmmunoassay Control (FOB)

by Newlink Biotech co., Ltd.

Ref F51-FOB

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-F51-FOBDQ Basic UDI-DI D-F51-FOBDQUDI-DIDate30 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
F51-FOB
Primary DI / UDI-DI
D-F51-FOBDQ
Basic UDI-DI
B-F51-FOBDQ
EMDN Code
W0102160801 Controls immunochem - rt & poc
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000045176
Authorised representative
VidaQuick Biotech S.L. ES-AR-000048138

Other devices from Newlink Biotech co., Ltd.

See all devices from Newlink Biotech co., Ltd. →

Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No