Unknown / Not in EUDAMED

Snapshot 2026-10-18 · Link to EUDAMED

GluNEO Lite S System

UDI-DI 08809115903099Basic UDI-DI 880911590OGSH01GL4A

Class C · IVDR · OSANG Healthcare Co., Ltd

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Identification

Model: OG-SH01-GL
EMDN: W0201060102
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

IVDR 793252

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-09-15 · Expiry 2029-03-27

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

OSANG Healthcare Co., Ltd

SRN KR-MF-000032605

KR · Anyang-si, Gyeonggi-do

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

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Examedin® FAST Strip 08800323058076
Examedin® FAST Strip 08800323058069
Examedin® FAST Strip 08800323058052
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Examedin® FAST System1 08800323058106
Examedin® FAST System2 08800323058090
GluNEO Lite Control solution (High) 08800323057758

Showing 12 of 49 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/gluneo-lite-s-system-3099 · UDI page: /udi/08809115903099

All devices from OSANG Healthcare Co., Ltd

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