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K-ASSAY H. pylori

by Kamiya Biomedical Company, LLC

Ref KAI-240

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00816426021136 Basic UDI-DI 00816426021136UDI-DIDate22 Jun 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  • Withdrawn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
H. pylori Test Reagent
Model / Reference
KAI-240
Primary DI / UDI-DI
00816426021136
Basic UDI-DI
B-00816426021136
EMDN Code
W0105010402 H. pylori antibody assays
Device Class
Class IVD General
EU 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

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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