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GluNEO Dual Blood Glucose Test Strip

by OSANG Healthcare Co., Ltd 4 variants

Ref OG-SH01-GDSModel OG-SH01-GD

Active European Union

CE IVDR

Valid until

14 Sep 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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 NumberIVDR 822531 Date15 Sep 2026IssuedStatusActive expires 14 Sep 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 822531 Active

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Sep 2026
    Expires
    14 Sep 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
GluNEO Dual Blood Glucose/Blood β-Ketone Monitoring System
Model / Reference
OG-SH01-GD, OG-SH01-GDS
Primary DI / UDI-DI
08800323059561
Basic UDI-DI
880911590OGSH01GD3S
EMDN Code
W0101060101 Glucose test strips
Device Class
Class C
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000032605
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from OSANG HEALTHCARE Co., Ltd.

See all devices from OSANG HEALTHCARE Co., Ltd. →

Properties

  • Reagent
  • Self Testing
  • Surgical Instrument
  • New Device

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No