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Urine Protein
EUDAMEDClass IVD General (EU MDR)
Ref B21302Model Urine Protein 240 mLRef B21300Model Urine Protein 216 mLRef B21301Model Urine Protein 108 mL
Identity
- Trade Name
- Urine Protein EUDAMED
- Device Name
- Urine Protein EUDAMED
- Model / Reference
- Urine Protein 240 mL EUDAMEDB21302 EUDAMEDUrine Protein 216 mL EUDAMEDB21300 EUDAMEDUrine Protein 108 mL EUDAMEDB21301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555611079 EUDAMED08683555611055 EUDAMED08683555611062 EUDAMED
- Basic UDI-DI
- B-08683555611079 EUDAMEDB-08683555611055 EUDAMEDB-08683555611062 EUDAMED
- EMDN Code
- W0101060299 URINE TESTING - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
Urine Protein by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — 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-08683555611079 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (3)
- EUDAMED 15133f7d-d5f5-4951-a94e-72e0eaf5a26e 61 fields · synced Oct 6, 2026
- EUDAMED 54b1e4b8-d577-4d96-b6d7-28f19cbae813 61 fields · synced May 17, 2026
- EUDAMED 84f90a66-67d7-4e1e-a6b9-6e5677be8a60 61 fields · synced May 17, 2026