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: 3mensio Workstation, CAAS A-Valve, CAAS IntraVascular, CAAS MR Solutions, CAAS Qardia.
Among these devices, 35 are declared active, 35 with a measuring function.
Devices declared under this manufacturer
- 3mensio Workstation
- CAAS A-Valve
- CAAS IntraVascular
- CAAS MR Solutions
- CAAS Qardia
- CAAS Workstation
- Caas Qardia
Showing 12 of 35 declared devices.
Catalogue references include 1.1, 10.3, 10.4, 2.1, 7.1, 7.5.
European nomenclature codes declared: Z11039082.
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 |
Device-level evidence
| Devices with a numeric GTIN | 33 |
|---|---|
| Found in the U.S. device database | 32 |
| Share | 97.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PIE MEDICAL IMAGING B.V. |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2020-10-20 |
Licence types: Single Device (3), Device Family (1).
Licensed under: 3MENSIO WORKSTATION, CAAS WORKSTATION, CAAS QARDIA, CAAS MR SOLUTIONS.
North American profile: Both markets. Pie Medical Imaging B.V. is registered in both the United States and Canada.