25-Hydroxy Vitamin D Chemiluminescence Immunoassay Kit
by Sansure Biotech Inc. 6 variants
Ref S2001E-25
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06955792736283 06955792736283 | Date4 Sep 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- 25-Hydroxy Vitamin D Chemiluminescence Immunoassay Kit
- Model / Reference
- S2001E-25
- Primary DI / UDI-DI
- 06955792736283
- Basic UDI-DI
- B-06955792736283
- EMDN Code
- W0102060309 25-hydroxyvitamin d
- Device Class
- Class IVD General
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000011392
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Sansure Biotech Inc.
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No