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Total Protein Assay Kit (Biuret Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH021105Model R: 60 mL×6Ref DTSH021104Model R: 60 mL×2Ref DTSH021106Model R: 90 mL×4
Identity
- Device Name
- Total Protein Assay Kit (Biuret Method) EUDAMED
- Model / Reference
- R: 60 mL×6 EUDAMEDDTSH021105 EUDAMEDR: 60 mL×2 EUDAMEDDTSH021104 EUDAMEDR: 90 mL×4 EUDAMEDDTSH021106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461360 EUDAMED06975225461353 EUDAMED06975225461377 EUDAMED
- Basic UDI-DI
- B-06975225461360 EUDAMEDB-06975225461353 EUDAMEDB-06975225461377 EUDAMED
- EMDN Code
- W01010230 TOTAL PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Total Protein Assay Kit (Biuret Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975225461360 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED d2a5244a-c90c-4d28-b7e0-97a83bb3fc86 61 fields · synced Sep 18, 2026
- EUDAMED 949bc91f-d604-4c0b-a2af-db94258fbf7a 61 fields · synced May 17, 2026
- EUDAMED 57ec99fe-593e-4b6a-b011-159db11a3230 61 fields · synced May 18, 2026