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KIT CYTOfast Urine24
EUDAMEDClass A (EU MDR)
Ref RFK0K0010Model Soluzione CYTOfast Urine
Identity
- Trade Name
- KIT CYTOfast Urine24 EUDAMED
- Device Name
- Soluzione CYTOfast Urine EUDAMED
- Model / Reference
- Soluzione CYTOfast Urine EUDAMEDRFK0K0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050999100399 EUDAMED
- Basic UDI-DI
- 805099910CYR003EE EUDAMED
- EMDN Code
- W01030705 FIXING REAGENTS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
KIT CYTOfast Urine24 by Hospitex International S.r.l. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 805099910CYR003EE | Class A | Active |
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Manufacturer
- Manufacturer
- Hospitex International S.r.l.
- EUDAMED SRN
- IT-MF-000041985
Sources (1)
- EUDAMED aceb37ce-4a03-44aa-806c-6e3da72bc1e5 61 fields · synced Jun 19, 2026