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On Call Sure Blood Glucose Meter

by Acon Biotech (Hangzhou) Co., Ltd. 3 variants

Ref G115-12UModel OGM-211

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 linked in EUDAMED

A group certificate may exist

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-G115-12UK3 Basic UDI-DI D-G115-12UK3UDI-DIDate8 Jul 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
OGM-211, G115-12U
Primary DI / UDI-DI
D-G115-12UK3
Basic UDI-DI
B-G115-12UK3
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class IVD Annex II List B
EU market of registration
Germany

Manufacturer details

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

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

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Properties

  • Self Testing
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (6)

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