VISION ESR Analyzer
by Shenzhen Yhlo Biotech Co., Ltd. 6 variants
Ref V6132Model VISION-C
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-V6132TZ D-V6132TZ | Date16 Mar 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- Withdrawn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
- VISION-C, V6132
- Primary DI / UDI-DI
- D-V6132TZ
- Basic UDI-DI
- B-V6132TZ
- EMDN Code
- W02029001 Erythrocyte sedimentation rate devices
- Device Class
- Class IVD General
- EU market of registration
- Italy
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
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No