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Ustekinumab CLIA kit (Chemiluminescence Immunoassay)

by Beijing Diagreat Biotechnologies Co., Ltd. 2 variants

Ref F11432-50Model 100 tests/box

Active European Union

CE IVDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697518250F1143229 Basic UDI-DI 06942293552115UDI-DIDate2 Mar 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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
100 tests/box, F11432-50
Primary DI / UDI-DI
06942293552115
Basic UDI-DI
697518250F1143229
Direct Marketing DI
06942293552115
EMDN Code
W0102080799 Autoimmune disease tdm - other
Device Class
Class B
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000019511
Authorised representative
Medunion S.L. ES-AR-000019366

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Properties

  • Reagent
  • Professional Testing
  • New Device

Other properties (8)

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