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On Call

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

Ref G125-12H-201Model OGC-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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6921756499990048XH Basic UDI-DI 06921756497897UDI-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  • Withdrawn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 Glucose Control Solution
Model / Reference
OGC-191, G125-12H-201
Primary DI / UDI-DI
06921756497897
Basic UDI-DI
6921756499990048XH
EMDN Code
W010106010801 Blood test strips controls
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

  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

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