ScreenPoint Medical
NL-MF-000000241 · Netherlands · Nijmegen
ScreenPoint Medical is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 4 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: 1.6.0, 1.7.0 and 1.7.1.
Among these devices, 6 are declared active.
Devices declared under this manufacturer
- Transpara
Catalogue references include 1.7.3 and 1.7.4, 2.0.0, 2.y.z, Version 1.6.0, Version 1.7.0 and 1.7.1.
European nomenclature codes declared: Z11030292.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SCREENPOINT MEDICAL (NL) · FDA 3015173173 |
| Devices in EUDAMED | 6 |
| Country of registration | Netherlands |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 83.3 % |
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | SCREENPOINT MEDICAL B.V. |
⚠️ A similar name exists; unverified — why.
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2020-11-27 |
Licence types: Device Family (1).
Licensed under: SCREENPOINT TRANSPARA.