SPECTRUM MEDICAL SRL
IT-MF-000009234 · Italy · Mirandola
SPECTRUM MEDICAL SRL is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 41 |
|---|
Most frequent device types declared: Quantum SuperPac Long Term, Quantum SuperPac, Quantum SuperPac Cardioplegia, Quantum PureFlow Standard Heat Exchanger W, Quantum Perfusion Blood oxygenator with integrated AF.
Among these devices, 38 are declared sterile.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SPECTRUM MEDICAL LTD (GB) · FDA 3006073153 |
| Devices in EUDAMED | 41 |
| Country of registration | Italy |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITD 1344656 1 | amended | 2028-04-08 |