Identity
- Trade Name
- UF-5000 EUDAMED
- Device Name
- Fully Automated Urine Particle Analyzer UF-5000 EUDAMED
- Model / Reference
- BN344411 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-BN344411X6 EUDAMED
- Basic UDI-DI
- B-BN344411X6 EUDAMED
- EMDN Code
- W020101020103 AUTOMATED URINE ANALYSERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Uf-5000 by Sysmex Corporation — 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-BN344411X6 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (1)
- EUDAMED caf6370d-39d7-4e7c-8650-fcdf04c7e3d0 61 fields · synced May 23, 2026