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ALK (2p23) Proximal - XL

by Leica Biosystems Newcastle Ltd United Kingdom EUDAMED

Ref KBI-XL001

EMDN W01060205

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08717973349013 Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
ALK (2p23) Break - XL for BOND
Model / Reference
KBI-XL001
Primary DI / UDI-DI
08717973349013
Basic UDI-DI
B-08717973349013
EMDN Code
W01060205 C-myc
Device Class
Class IVD General
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 (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

Sources (1)

  • EUDAMED 943a77d6-e275-4da1-ae44-990d9c789846 61 fields · synced 24 Oct 2026