Skip to content

KENZA 450TX - AUTOMATIC BIOCHEMISTRY ANALYSER, including accessories

by Biolabo France EUDAMED

Ref KENZA 450TX EMDN W0201010102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number376017308K4R5 Basic UDI-DIDate30 Aug 2023RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Kenza 450TX
Model / Reference
KENZA 450TX
Primary DI / UDI-DI
03760173087204
Basic UDI-DI
376017308K4R5
Direct Marketing DI
03760173087204
EMDN Code
W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
FR-MF-000001633

Other devices from Biolabo

See all devices from Biolabo →

Properties & raw data

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

Sources (1)

  • EUDAMED dc5b9352-7e47-40f6-bee5-6484538e7a06 61 fields · synced 22 Oct 2026