Unicorn-IL-6
by Shenzhen Drawray Biotech Co., Ltd. 2 variants
Ref DT0078Model 5 Tests/kit 20 Tests/kit, 5 Tests/kit
Active
CE IVDR CE IVDD
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/IVDD | Number6973224890076AT | Date7 Jul 2026 | StatusActive |
| European Union | CE/IVDR | Number6973224890076AT | Date7 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Specification
- Model / Reference
- 5 Tests/kit 20 Tests/kit, DT0078, 5 Tests/kit
- Primary DI / UDI-DI
- 06973224894196, D-DT00787P
- Basic UDI-DI
- 6973224890076AT, B-DT00787P
- EMDN Code
- W01030609 Interleukin 6 (il-6)
- Device Class
- Class CClass IVD General
- EU market of registration
- NetherlandsSpain
Manufacturer details
- EUDAMED SRN
- CN-MF-000008763
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Shenzhen Drawray 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