Sample Diluent
by Shenzhen Drawray Biotech Co., Ltd. 11 variants
Ref DC10033Model A-1: 5mL×2bottles; A-3: 45mL×2bottles; B-1: 5mL×2bottles; B-3: 45mL×2bottles; D-1: 5mL×2bottles; D-3: 120μL×100bottles; D-4: 45mL×2bottles; G-1: 5mL×2bottles; G-3: 45mL×2bottles; H-1: 5mL×2bottles; H-3: 45mL×2bottles
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number6973224890043AC 06973224894455 | Date23 Dec 2025 | 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- Withdrawn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/IVDR Active
Specification
- Device Name
- Sample Diluent
- Model / Reference
- A-1: 5mL×2bottles, A-3: 45mL×2bottles, B-1: 5mL×2bottles, B-3: 45mL×2bottles, D-1: 5mL×2bottles, D-3: 120μL×100bottles, D-4: 45mL×2bottles, G-1: 5mL×2bottles, G-3: 45mL×2bottles, H-1: 5mL×2bottles, H-3: 45mL×2bottles, DC10033
- Primary DI / UDI-DI
- 06973224894455
- Basic UDI-DI
- 6973224890043AC
- EMDN Code
- W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
- Device Class
- Class A
- EU market of registration
- Netherlands
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 (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No