ELEMENT Blood Glucose Control Solution (Normal)
by OSANG Healthcare Co., Ltd South Korea EUDAMED
Ref INFCN21APTModel INFCH21APT EMDN W010106010801
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08809115904638 | Date9 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- ELEMENT Blood Glucose Control Solution (High)
- Model / Reference
- INFCH21APT, INFCN21APT
- Primary DI / UDI-DI
- 08809115904638
- Basic UDI-DI
- B-08809115904638
- EMDN Code
- W010106010801 Blood test strips controls
- Device Class
- Class IVD Annex II List B
- Market of Registration
- Portugal
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 08809115904638|B-08809115904638