Identity
- Trade Name
- RF-Q EUDAMED
- Device Name
- RF-Q EUDAMED
- Model / Reference
- 7711 EUDAMED7784 EUDAMED7733 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172971779 EUDAMED08053172971793 EUDAMED08053172971786 EUDAMED
- Basic UDI-DI
- B-08053172971779 EUDAMEDB-08053172971793 EUDAMEDB-08053172971786 EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Rf-Q by Giesse Diagnostics Srl — 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-08053172971779 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (3)
- EUDAMED 69a7702f-b59c-412e-be9f-f321eef58f5d 61 fields · synced Sep 17, 2026
- EUDAMED 64189eb9-94d1-4257-ba41-9361cdf6fadf 61 fields · synced May 18, 2026
- EUDAMED 12c7a231-940a-4d95-ae30-f6b13c26d8cb 61 fields · synced May 18, 2026