Pie Medical Imaging B.V.
NL-MF-000001540 · Netherlands · Maastricht
Pie Medical Imaging B.V. is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 23 |
|---|---|
| Class IIb | 12 |
Most frequent device types declared: CAAS Workstation, 3mensio Workstation, CAAS A-Valve, CAAS IntraVascular, CAAS MR Solutions.
Among these devices, 35 are declared active, 35 with a measuring function.
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 | PIE MEDICAL IMAGING B.V. (NL) · FDA 9710122 |
| Devices in EUDAMED | 35 |
| Country of registration | Netherlands |