Identity
- Trade Name
- Soluzione di sistema (1:10001) - "Rinse" EUDAMED
- Device Name
- Soluzione di Sistema/Systemic Solution EUDAMED
- Model / Reference
- 3973 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172972493 EUDAMED
- Basic UDI-DI
- 805317297SYSSOLU4 EUDAMED
- Direct Marketing DI
- 08053172972493 EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Soluzione di sistema (1:10001) - "Rinse" by Giesse Diagnostics Srl — 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 | 805317297SYSSOLU4 | Class A | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (1)
- EUDAMED 81ca5dab-a24e-4a03-a13c-52fdeb6e9459 61 fields · synced Jul 14, 2026