GluNEO Dual Control Solution Level 2
by OSANG Healthcare Co., Ltd South Korea EUDAMED
Ref OG-SH01-GDC-2Model OG-SH01-GD EMDN W010106010801
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number880911590OGSH01GD3S | Date11 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IVDR 822531 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 2797
- Issued
- 15 Sep 2026
- Expires
- 14 Sep 2031
Specification
- Device Name
- GluNEO Dual Blood Glucose/Blood β-Ketone Monitoring System
- Model / Reference
- OG-SH01-GD, OG-SH01-GDC-2
- Primary DI / UDI-DI
- 08800323059509
- Basic UDI-DI
- 880911590OGSH01GD3S
- EMDN Code
- W010106010801 Blood test strips controls
- Device Class
- Class C
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- KR-MF-000032605
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from OSANG HEALTHCARE Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
Sources (1)
- EUDAMED 08800323059509|880911590OGSH01GD3S