Unicorn-Vitamin B12
by Shenzhen Drawray Biotech Co., Ltd. 2 variants
Ref DT0125Model 20 tests/kit
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-DT012577 | Date8 Jul 2026 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- Model / Reference
- 20 tests/kit, DT0125
- Primary DI / UDI-DI
- D-DT012577
- Basic UDI-DI
- B-DT012577
- EMDN Code
- W0102070204 Vitamin b12
- Device Class
- Class IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000008763
- Authorised representative
- Medunion S.L. ES-AR-000019366
Other devices from Shenzhen Drawray Biotech Co., Ltd.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No