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K-ASSAY Apo AII / CII / CIII / E Control

by Kamiya Biomedical Company, LLC

Ref K315C-4M

Active European Union

CE IVDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00816426021662 Basic UDI-DI 00816426021662UDI-DIDate6 Jul 2026RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Apo AII / CII / CIII / E Control
Model / Reference
K315C-4M
Primary DI / UDI-DI
00816426021662
Basic UDI-DI
B-00816426021662
EMDN Code
W0102152099 Controls- immunochemistry - other
Device Class
Class IVD General
EU 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