Dedalus Italia SpA
IT-MF-000009127 · Italy · Firenze
Dedalus Italia SpA is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 26 |
|---|---|
| Class IIa | 6 |
Most frequent device types declared: ATMOSphere, CONCERTO IVD, ELEKTRA, ER4H FirstAid Web, HALIA.
Among these devices, 20 are declared active.
Devices declared under this manufacturer
- ATMOSphere Hematology
- DNLAB IVD CORE
- ELEKTRA
- ER4H FirstAid Web (Mobile)
- FARMASAFE@
- Farmasafe@
- GiPSEweb
- GiPSEweb (Mobile)
- GiPSEweb (mobile)
- HALIA
- P4C
- PENTAGRAMMA
Showing 12 of 60 declared devices.
Catalogue references include ELEKTRA, ER4H FirstAid Web (Mobile), FARMASAFE@, GiPSEweb, GiPSEweb (mobile), P4C.
European nomenclature codes declared: V92, W02079092, Z12040292, Z12040182.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 60 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 60 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Dedalus Italia SpA was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 00290-A | issued | 2027-11-15 |