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Examedin® FAST Control solution (Low)

by OSANG Healthcare Co., Ltd South Korea EUDAMED

Ref OG-SH31-GLC-1Model OG-SH01-GL

EMDN W010106010801

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880911590OGSH01GL4A Basic UDI-DIDate1 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 793252 Supplemented

    Technical documentation EU IVDR

    Notified body
    Notified body 2797
    Issued
    15 Sep 2026
    Expires
    27 Mar 2029
    Reason
    Change approved

Specification

EUDAMED · synced 24 Oct 2026

Device Name
GluNEO Lite S Blood Glucose Monitoring System
Model / Reference
OG-SH01-GL, OG-SH31-GLC-1
Primary DI / UDI-DI
08800323058014
Basic UDI-DI
880911590OGSH01GL4A
Direct Marketing DI
08800323058014
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class C
Market of Registration
Portugal

Manufacturer details

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

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 08800323058014|880911590OGSH01GL4A 61 fields · synced 24 Oct 2026