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Total Protein Reagent Kit (biuret Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3016498Model R:5x50mL, Calibration sample: 2mLRef 3019473Model R:1L, Calibration sample: 2mLRef 3000529Model R: 4x50mL,Calibration sample: 2mLRef 3000528Model R: 2x80mL,Calibration sample: 2mLRef 3000526
Identity
- Trade Name
- TOTAL PROTEIN REAGENT KIT (BIURET METHOD) EUDAMED
- Device Name
- TOTAL PROTEIN REAGENT KIT (BIURET METHOD) EUDAMED
- Model / Reference
- R:5x50mL, Calibration sample: 2mL EUDAMED3016498 EUDAMEDR:1L, Calibration sample: 2mL EUDAMED3019473 EUDAMEDR: 4x50mL,Calibration sample: 2mL EUDAMED3000529 EUDAMEDR: 2x80mL,Calibration sample: 2mL EUDAMED3000528 EUDAMED3000526 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259289 EUDAMED06925794581280 EUDAMED06942202259319 EUDAMED06942202259302 EUDAMED06942202240881 EUDAMED
- Basic UDI-DI
- B-06942202259289 EUDAMEDB-06925794581280 EUDAMEDB-06942202259319 EUDAMEDB-06942202259302 EUDAMEDB-06942202240881 EUDAMED
- EMDN Code
- W01010230 TOTAL PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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 Reagent Kit (biuret Method) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06942202259289 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED a22527c8-37d6-4475-8c75-1d6c09a4365d 61 fields · synced Jul 18, 2026
- EUDAMED 55d2f540-cfd6-493b-8724-e4a41145e76a 61 fields · synced May 17, 2026
- EUDAMED b24f4b76-9052-4edf-a4fc-d76fafe785c6 61 fields · synced May 18, 2026
- EUDAMED 1cb0efd3-7b3b-4ea3-bbbf-757ec584f95a 61 fields · synced May 18, 2026
- EUDAMED 5e7499f9-58dd-4e98-9f49-1f1ee0c0595e 61 fields · synced May 19, 2026