Philips Medical Systems Nederland B.V.
NL-MF-000001489 · Netherlands · Best
Philips Medical Systems Nederland B.V. is registered in the European database on medical devices as a manufacturer, with 493 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 322 |
|---|---|
| Class IIb | 162 |
| other | 6 |
| Class I | 3 |
Most frequent device types declared: IntelliSpace Cardiovascular, Xper Information Management System , Pathology Scanner SG60i 1.x, Zenition 50, AV Viewer.
Among these devices, 29 are declared sterile, 2 reusable, 406 active, 77 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 | Philips Medical Systems Nederland B.V. (NL) · FDA 3015777306 |
| Devices in EUDAMED | 493 |
| Country of registration | Netherlands |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1135905-1 | supplemented | 2030-06-04 |
2243163CE01 | supplemented | 2030-07-01 |