Uric Acid Assay Kit (Oxidase Method)
by Da Te Bioengineering Technology Co., LTD. China EUDAMED
Ref DTSH030906Model R1: 60 mL×4; R2: 15 mL×4 EMDN W01010232
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06975225461438 | Date6 Feb 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Uric Acid Assay Kit (Oxidase Method)
- Model / Reference
- R1: 60 mL×4, R2: 15 mL×4, DTSH030906
- Primary DI / UDI-DI
- 06975225461438
- Basic UDI-DI
- B-06975225461438
- EMDN Code
- W01010232 Uric acid
- Device Class
- Class IVD General
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000028832
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 14261382-86f7-4f0c-87e0-58febd01b4a6