Skip to content

K-ASSAY Apo AII

by Kamiya Biomedical Company, LLC EUDAMED

Active European Union

Ref KAI-003

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00816426020023 Basic UDI-DIDate11 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  • Withdrawn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 AII Reagent
Model / Reference
KAI-003
Primary DI / UDI-DI
00816426020023
Basic UDI-DI
B-00816426020023
EMDN Code
W0102010402 Apolipoprotein a II
Device Class
Class IVD General
Market of Registration
Czechia

Manufacturer details

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

Other devices from Kamiya Biomedical Company, LLC

See all devices from Kamiya Biomedical Company, LLC →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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