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K-ASSAY Apo E Calibrator

by Kamiya Biomedical Company, LLC EUDAMED

Active European Union

Ref KAI-025C

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00816426020436 Basic UDI-DIDate26 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Apo E Calibrator
Model / Reference
KAI-025C
Primary DI / UDI-DI
00816426020436
Basic UDI-DI
B-00816426020436
EMDN Code
W0102010499 Lipoproteins - other
Device Class
Class IVD General
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
US-MF-000002769
Authorised representative
Advena Limited MT-AR-000000234

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Properties

  • Human Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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