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 Perfusion Blood Oxygenator Long Term, Quantum Perfusion Centrifugal Blood Pump, Quantum Perfusion Centrifugal Blood Pump with Integrated Pressure Sens, Quantum PureFlow Cardioplegia Heat Exchanger W, Quantum PureFlow Connector Adaptor Kit CPC.
Among these devices, 38 are declared sterile.
Devices declared under this manufacturer
- Quantum Perfusion
- Quantum PureFlow
- Quantum SuperPAC
- Quantum SuperPac
Showing 12 of 41 declared devices.
Catalogue references include CONN-HX2, HX11V-S0W, SPC160A-D4, SPC160A-D5, SPC200A-D1, SPC200A-D4.
European nomenclature codes declared: C03010101, C030199, C030102, C03010102, C030180.
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 |
Device-level evidence
| Devices with a numeric GTIN | 41 |
|---|---|
| Found in the U.S. device database | 18 |
| Share | 43.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SPECTRUM MEDICAL LTD. |
North American profile: Both markets. SPECTRUM MEDICAL SRL is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITD 1344656 1 | amended | 2028-04-08 |