HumaCombina 10
by Beijing HumaDX Tech Co., Ltd. EUDAMED
Active
Ref 22100Model 100T
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06976343804053 | Date11 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- HumaCombina 10
- Model / Reference
- 100T, 22100
- Primary DI / UDI-DI
- 06976343804053
- Basic UDI-DI
- B-06976343804053
- EMDN Code
- W0101060106 Urea test strips
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000029051
- Authorised representative
- Human Gesellschaft für Biochemica und Diagnostica mbH DE-AR-000025586
Other devices from Beijing HumaDX Tech Co., Ltd.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No