Urine Microalbumin Creatinine Ratio Test Kit (Fluorescence Immunoassay)
by Wuxi Biohermes Bio & Medical Technology Co., Ltd. 5 variants
Ref BF-S095Model BF S09
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-CNMF000014455-BF-S095S4 D-CNMF000014455-BF-S095S4 | Date2 Jun 2026 | 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- Withdrawn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
- Device Name
- Urine Microalbumin Creatinine Ratio Test Kit (Fluorescence Immunoassay)
- Model / Reference
- BF S09, BF-S095
- Primary DI / UDI-DI
- D-CNMF000014455-BF-S095S4
- Basic UDI-DI
- B-CNMF000014455-BF-S095S4
- EMDN Code
- W0101060299 Urine testing - other
- Device Class
- Class IVD General
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000014455
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No