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BOND Hybridization Solution

by Leica Biosystems Newcastle Ltd EUDAMED

Active European Union

Ref AR9037

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number50553313RNAHYB000062Z Basic UDI-DIDate24 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  • Withdrawn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
AR9037
Primary DI / UDI-DI
05055331327307
Basic UDI-DI
50553313RNAHYB000062Z
Direct Marketing DI
05055331327307
EMDN Code
W0103010199 Reagents for (automated) haematology analyzer - other
Device Class
Class A
Market of Registration
Germany

Manufacturer details

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

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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