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Anti-Cytokeratin 16

by DB Biotech, a.s. EUDAMED

Active European Union

Ref DB 100-RTU-7, DB 100-0.5, DB 100-RTU-15, DB 100-0.2Model DB 100

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number85850389DB100KH Basic UDI-DIDate25 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
DB 100, DB 100-RTU-7, DB 100-0.5, DB 100-RTU-15, DB 100-0.2
Primary DI / UDI-DI
08585038902134, 08585038902103, 08585038902127, 08585038902349
Basic UDI-DI
85850389DB100KH
EMDN Code
W01030705 Fixing reagents (histology/cytology)
Device Class
Class C
Market of Registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000051838

Other devices from DB Biotech, a.s.

See all devices from DB Biotech, a.s. →

Properties

Show properties
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No