GluNEO Dual Blood Glucose/Blood β-Ketone Monitoring System

Name: GluNEO Dual Blood Glucose/Blood β-Ketone Monitoring System
Brand: OSANG Healthcare Co., Ltd
SKU: 08800323059196

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

Identification

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.

SRN KR-MF-000032605

KR · Anyang-si, Gyeonggi-do

manufacturer

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

Name	UDI-DI	Certificate
GluNEO Dual Blood Glucose/Blood β-Ketone Monitoring System	08800323059202	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GluNEO Dual Blood Glucose/Blood β-Ketone Monitoring System	08800323059189	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GluNEO Dual Blood Glucose/Blood β-Ketone Monitoring System	08800323059219	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GluNEO Dual Blood Glucose Test Strip	08800323055884	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GluNEO Dual Blood Glucose Test Strip	08800323055877	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GluNEO Dual Blood Glucose Test Strip	08800323059554	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GluNEO Dual Blood Glucose Test Strip	08800323059561	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GluNEO Dual Control Solution Level 1	08800323059516	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED
GluNEO Dual Control Solution Level 2	08800323059509	Certificate valid Snapshot 2026-10-31 · Link to EUDAMED