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KENZA 240ISE - AUTOMATIC BIOCHEMISTRY ANALYSER with ISE Module, including accessories

by Biolabo

Ref KENZA 240ISE

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number376017308K2QZ Basic UDI-DI 03760173087198UDI-DIDate30 Aug 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Kenza 240TX
Model / Reference
KENZA 240ISE
Primary DI / UDI-DI
03760173087198
Basic UDI-DI
376017308K2QZ
Direct Marketing DI
03760173087198
EMDN Code
W0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
FR-MF-000001633

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Properties

  • 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