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Anti-Ki-67

by DB Biotech, a.s. Slovakia EUDAMED

Ref DB 318-0.2Model DB 318 EMDN W01030705

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number85850389DB318LE 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
DB 318, DB 318-0.2
Primary DI / UDI-DI
08585038904695
Basic UDI-DI
85850389DB318LE
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 991863b5-8b4a-49ff-a24d-db4c454a30ff 61 fields · synced 25 Oct 2026