Urea, creatinine, uric acid test card (dry chemical method)
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. EUDAMED
Active
Ref 10 pcs/boxModel DiaCard-4
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06934822535287 | Date16 Nov 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Urea, creatinine, uric acid test card (dry chemical method)
- Model / Reference
- DiaCard-4, 10 pcs/box
- Primary DI / UDI-DI
- 06934822535287
- Basic UDI-DI
- B-06934822535287
- EMDN Code
- W0101060499 Multiple parameters poc - other
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000016839
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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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