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Cytokeratin 14 Antibody Reagents (Immunohistochemistry)

by Beijing Biosynthesis Biotechnology Co., Ltd.

Ref 701

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697707559BH0701CGD Basic UDI-DI 06977075597015UDI-DIDate9 May 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Cytokeratin 14 Antibody Reagents (Immunohistochemistry)
Model / Reference
701
Primary DI / UDI-DI
06977075597015
Basic UDI-DI
697707559BH0701CGD
Direct Marketing DI
06977075597015
EMDN Code
W01030708 Stain solutions (histology/cytology)
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000040500
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Beijing Biosynthesis Biotechnology Co., Ltd.

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device

Other properties (7)

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