adia Control solution (High)
Ref OG-SH03-ADC-3Model OG-SH03-AD (D48531)
adia Control solution (High) (OG-SH03-ADC-3) is a Class C device made by OSANG HEALTHCARE Co., Ltd., registered in EUDAMED on 12 Jun 2026 (Basic UDI-DI 880911590OGSH03AD3J), active as of 7 Nov 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number880911590OGSH03AD3J 08800323058342 | Date12 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 880911590OGSH03AD3J
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device name
- adia System
- Model / reference
- OG-SH03-AD (D48531), OG-SH03-ADC-3
- Primary DI / UDI-DI
- 08800323058342
- Basic UDI-DI
- 880911590OGSH03AD3J
- Direct marketing DI
- 08800323058342
- EMDN code
- W010106010801 Blood test strips controls
- Device class
- Class C
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000032605
- Authorised representative
- Obelis s.a. BE-AR-000000106
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