GluNEO Plus Strip
by OSANG Healthcare Co., Ltd South Korea EUDAMED
Ref OG-SH11-GPS-2Model OG-SH01-GPS-2 EMDN W0101060101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number880911590OGSH01GP4J | Date4 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IVDR 793280 Supplemented
Technical documentation EU IVDR
- Notified body
- Notified body 2797
- Issued
- 15 Sep 2026
- Expires
- 27 Mar 2029
- Reason
- Change approved
Specification
- Device Name
- GluNEO Plus S Strip
- Model / Reference
- OG-SH01-GPS-2, OG-SH11-GPS-2
- Primary DI / UDI-DI
- 08800323057222
- Basic UDI-DI
- 880911590OGSH01GP4J
- Direct Marketing DI
- 08800323057222
- EMDN Code
- W0101060101 Glucose test strips
- Device Class
- Class C
- Market of Registration
- Poland
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 (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 08800323057222|880911590OGSH01GP4J