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On Call

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

Ref G115-10H-201Model OGM-191

Active European Union

CE IVDR

Valid until

20 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 Number6921756499990045XB Basic UDI-DI 06921756497774UDI-DIDate23 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  • Withdrawn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 Extra Blood Glucose Monitoring System
Model / Reference
OGM-191, G115-10H-201
Primary DI / UDI-DI
06921756497774
Basic UDI-DI
6921756499990045XB
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

  • Microbial Substances
  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (5)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Companion Diagnostics: No
  • New Device: No