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On Call

by Acon Biotech (Hangzhou) Co., Ltd. 8 variants

Ref GK134-10A-270Model OGS-161

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-6977GK13410A2704A Basic UDI-DI D-6977GK13410A2704AUDI-DIDate13 Oct 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  • Withdrawn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
On Call Blood Ketone Test Strips
Model / Reference
OGS-161, GK134-10A-270
Primary DI / UDI-DI
D-6977GK13410A2704A
Basic UDI-DI
B-6977GK13410A2704A
EMDN Code
W0101060110 Ketone test strips (β-hydroxybutyrate test strips)
Device Class
Class IVD General
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000006977
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Acon Biotech (Hangzhou) Co., Ltd.

See all devices from Acon Biotech (Hangzhou) Co., Ltd. →

Properties

  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No