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GluNEO Dual Blood Glucose Test Strip

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

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Class C · IVDR · OSANG Healthcare Co., Ltd

Identification

Model
OG-SH01-GD
Issuing agency
GS1
Device status
active
Sterile
No

Certificates

IVDR 822531

EU technical documentation assessment · valid

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

Valid from 2026-09-15 · Expiry 2031-09-14

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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Snapshot 2026-10-31 · Link to EUDAMED

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GluNEO Dual Blood Glucose/Blood β-Ketone Monitoring System08800323059189
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GluNEO Dual Blood Glucose/Blood β-Ketone Monitoring System08800323059219
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GluNEO Dual Blood Glucose Test Strip08800323055884
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Snapshot 2026-10-31 · Link to EUDAMED

GluNEO Dual Blood Glucose Test Strip08800323055877
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Snapshot 2026-10-31 · Link to EUDAMED

GluNEO Dual Blood Glucose Test Strip08800323059554
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Snapshot 2026-10-31 · Link to EUDAMED

GluNEO Dual Control Solution Level 108800323059516
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Snapshot 2026-10-31 · Link to EUDAMED

GluNEO Dual Control Solution Level 208800323059509
Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/gluneo-dual-blood-glucose-test-strip-9561 · UDI page: /udi/08800323059561

All devices from OSANG Healthcare Co., Ltd