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Cuvette-8U

by Biolis Medical Corp. EUDAMED

Active European Union

Ref 23-07-0055DModel Reaction Cuvette

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number458026201RCRX Basic UDI-DIDate9 Mar 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
Reaction Cuvette, 23-07-0055D
Primary DI / UDI-DI
04580262020030
Basic UDI-DI
458026201RCRX
EMDN Code
W0503010203 Samples analyses, plastic cuvettes
Device Class
Class A
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
JP-MF-000025468
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No