Identity
- Trade Name
- Total Protein EUDAMED
- Device Name
- Total Protein EUDAMED
- Model / Reference
- HB0190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035101308 EUDAMED
- Basic UDI-DI
- B-05404035101308 EUDAMED
- EMDN Code
- W01010230 TOTAL PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Total Protein by Cypress Diagnostics — 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-05404035101308 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (1)
- EUDAMED e4501e92-db90-4daa-a67e-baf8e7b6871a 61 fields · synced Jul 21, 2026