25-hydroxy-vitamin D test (Up-converting Phosphor Technology)
by Beijing Hotgen Biotech Co., Ltd. 2 variants
Ref HGUPT03Model Please see the IFU
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697029753307LF 06936700406689 | Date21 Jan 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Please see the IFU, HGUPT03
- Primary DI / UDI-DI
- 06936700406689
- Basic UDI-DI
- 697029753307LF
- EMDN Code
- W0102060309 25-hydroxyvitamin d
- Device Class
- Class B
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000015566
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Beijing Hotgen Biotech Co., Ltd.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No