LIA-Diabetes-Profile
by Shenzhen Yhlo Biotech Co., Ltd. 6 variants
Ref L89408G2
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-L89408G2W6 D-L89408G2W6 | Date27 Feb 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- Withdrawn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
- Model / Reference
- L89408G2
- Primary DI / UDI-DI
- D-L89408G2W6
- Basic UDI-DI
- B-L89408G2W6
- EMDN Code
- W01021499 Multiple immunochemistry reagents - other
- Device Class
- Class IVD General
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000001137
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Shenzhen Yhlo Biotech Co., Ltd.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No