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Total Protein In Urine Reagent Kit (turbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3016535Model R1: 4x20mL, R2: 4x9mL, Calibration sample: 1mL, Control: 2x1mLRef 3004410Model R1: 1x20mL, R2: 1x9mL, Calibration sample: 1mLRef 3021165Model R1: 4x20mL, R2: 4x9mL，Calibration sample: 1mLRef 3023226Ref 3021625Ref 3021698
Identity
- Trade Name
- TOTAL PROTEIN IN URINE REAGENT KIT (TURBIDIMETRIC METHOD) EUDAMED
- Device Name
- TOTAL PROTEIN IN URINE REAGENT KIT (TURBIDIMETRIC METHOD) EUDAMED
- Model / Reference
- R1: 4x20mL, R2: 4x9mL, Calibration sample: 1mL, Control: 2x1mL EUDAMED3016535 EUDAMEDR1: 1x20mL, R2: 1x9mL, Calibration sample: 1mL EUDAMED3004410 EUDAMEDR1: 4x20mL, R2: 4x9mL，Calibration sample: 1mL EUDAMED3021165 EUDAMED3023226 EUDAMED3021625 EUDAMED3021698 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259722 EUDAMED06942202259708 EUDAMED06942202259739 EUDAMED06942202213410 EUDAMED06925794593016 EUDAMED06925794593009 EUDAMED
- Basic UDI-DI
- B-06942202259722 EUDAMEDB-06942202259708 EUDAMEDB-06942202259739 EUDAMEDB-06942202213410 EUDAMEDB-06925794593016 EUDAMEDB-06925794593009 EUDAMED
- EMDN Code
- W01010299 SUBSTRATES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 In Urine Reagent Kit (turbidimetric Method) by Dirui Industrial 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-06942202259722 | 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 (6)
- EUDAMED 8ac3e645-86be-4a28-84f9-8f9bd54b55fe 61 fields · synced Jul 31, 2026
- EUDAMED b0eaf641-b4a6-4165-b1c5-036ac94607a9 61 fields · synced May 17, 2026
- EUDAMED 92d0d37a-c6ae-4dc9-9006-f1c0438cd339 61 fields · synced May 17, 2026
- EUDAMED e7cfe479-8235-4d89-8ef1-8e5bf93b027e 61 fields · synced Jul 17, 2026
- EUDAMED 1a214ddb-26a1-4273-aac2-277c71fa3a8c 61 fields · synced Jul 19, 2026
- EUDAMED 74e675ff-ba66-4a40-b215-fae8ac78dab6 61 fields · synced Jul 31, 2026