Total Protein Kit (Biuret Method)
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 3 variants
Ref TP1102, TPⅡ0102, TP0105, TP0104, 105-000823-00, 105-001598-00, 105-015587-00, 105-015586-00, TP0102, TPⅡ0103Model 105-000823-00、105-000862-00、105-001598-00, 105-015586-00、105-015587-00、105-015588-00
Active
CE IVDR CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-06944904083773 | Date13 May 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-06944904083773 | Date13 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Model / Reference
- TP1102, TPⅡ0102, TP0105, TP0104, 105-000823-00、105-000862-00、105-001598-00, 105-000823-00, 105-001598-00, 105-015586-00、105-015587-00、105-015588-00, 105-015587-00, 105-015586-00, TP0102, TPⅡ0103
- Primary DI / UDI-DI
- 06944904083773, 06936415926373, 06944904025575, 06944904026183, 06944904024790, 06936415926380
- Basic UDI-DI
- B-06944904083773, B-06936415926373, B-06944904025575, B-06944904026183, 694490400041TP*********A2, 69449040004BTP*********UJ, B-06944904024790, B-06936415926380
- EMDN Code
- W01010230 Total protein
- Device Class
- Class IVD GeneralClass B
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No