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On Call

by Acon Biotech (Hangzhou) Co., Ltd. 45 variants

Ref G115-13U-201Model OGM-211

Active European Union

CE IVDR

Valid until

12 Jul 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

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 Number6921756499990040WZ Basic UDI-DI 06921756470364UDI-DIDate24 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
On Call Sure Blood Glucose Meter
Model / Reference
OGM-211, G115-13U-201
Primary DI / UDI-DI
06921756470364
Basic UDI-DI
6921756499990040WZ
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class C
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

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

Other properties (7)

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