Skip to content

Tissue Digestion Kit II

by Leica Biosystems Newcastle Ltd United Kingdom EUDAMED

Ref KBI-60004 EMDN W01030703

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number871797334PTKTD200007CE Basic UDI-DIDate3 Jun 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  • Withdrawn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 24 Oct 2026

Model / Reference
KBI-60004
Primary DI / UDI-DI
08717973347484
Basic UDI-DI
871797334PTKTD200007CE
Direct Marketing DI
08717973347484
EMDN Code
W01030703 DNA in situ hybridisation reagents
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000020595
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Leica Biosystems Newcastle, Limited

See all devices from Leica Biosystems Newcastle, Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 323047ba-e7e5-430c-8890-a0834eab3ae0 61 fields · synced 24 Oct 2026