Unknown / Not in EUDAMED

Snapshot 2026-10-17 · Link to EUDAMED

GluNEO Plus System1

UDI-DI 08800323057277Basic UDI-DI 880911590OGSH01GP4J

Class C · IVDR · OSANG Healthcare Co., Ltd

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Identification

Model: OG-SH01-GPS-2
EMDN: W0201060102
Issuing agency: GS1
Device status: active
Sterile: No

Certificates

IVDR 793280

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)

Related UDI-DIs

GluNEO Plus Control solution (High) 08800323057185
GluNEO Plus Control solution (Low) 08800323057208
GluNEO Plus Control solution (Normal) 08800323057192
GluNEO Plus Meter 08800323057253
GluNEO Plus S Control solution (High) 08809115902849
GluNEO Plus S Control solution (Low) 08809115902863
GluNEO Plus S Control solution (Normal) 08809115902856
GluNEO Plus S Meter 08809115902917
GluNEO Plus S Strip 08809115902894
GluNEO Plus S Strip 08809115902870
GluNEO Plus S Strip 08809115902887
GluNEO Plus S Strip 08809115902900

Showing 12 of 21 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/gluneo-plus-system1-7277 · UDI page: /udi/08800323057277

All devices from OSANG Healthcare Co., Ltd

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