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Examedin® FAST System2

by OSANG Healthcare Co., Ltd

Ref OG-SH31-GL-2Model OG-SH01-GL

Active European Union

CE IVDR

Valid until

27 Mar 2029

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIVDR 793252 Date15 Sep 2026IssuedStatusActive expires 27 Mar 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 793252 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Sep 2026
    Expires
    27 Mar 2029
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
GluNEO Lite S Blood Glucose Monitoring System
Model / Reference
OG-SH01-GL, OG-SH31-GL-2
Primary DI / UDI-DI
08800323058090
Basic UDI-DI
880911590OGSH01GL4A
Direct Marketing DI
08800323058090
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class C
EU market of registration
Portugal

Manufacturer details

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

Other devices from OSANG HEALTHCARE Co., Ltd.

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Properties

  • Reagent
  • Self Testing
  • New Device

Other properties (8)

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