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MET (7q31) - XL

by Leica Biosystems Newcastle Ltd United Kingdom EUDAMED

Ref KBI-XL003

EMDN W01060205

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08717973349037 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
MET (7q31) / SE 7 (D7Z1) - XL for BOND
Model / Reference
KBI-XL003
Primary DI / UDI-DI
08717973349037
Basic UDI-DI
B-08717973349037
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

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 0800824e-2cb7-405d-b277-76206effb760 61 fields · synced 24 Oct 2026