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Glucose/Ketone/Uric Acid/Total Cholesterol Meter

by Aceso Laboratories, Inc. 2 variants

Ref EKA01-GKUC

Active European Union

CE IVDR

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/IVDR Number0810164510005NB Basic UDI-DI 00810164510372UDI-DIDate13 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
EKA01-GKUC
Primary DI / UDI-DI
00810164510372
Basic UDI-DI
0810164510005NB
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000045175
Authorised representative
VidaQuick Biotech S.L. ES-AR-000048138

Other devices from Aceso Laboratories, Inc.

See all devices from Aceso Laboratories, Inc. →

Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
  • New Device

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No