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 |
| Class I | 3 |
Most frequent device types declared: AV Viewer, BV Endura, IntelliSpace Cardiovascular, Pathology Scanner SG60i 1.x, Radiology Operations Command Center Console.
Among these devices, 29 are declared sterile, 2 reusable, 406 active, 77 with a measuring function.
Devices declared under this manufacturer
- Azurion 7 M20
- Brilliance Big Bore System Upgrade
- Ingenia 3.0T
- Lateral Array Coil Left VT
- MR 5300
- MR 7700
- Medial Array Coil VG GE750
- Medial Array Coil VT
- NM Suite
- SmartCT
- SmartPath to MR 7700
- Standard mattress for Azurion series 7
Showing 12 of 493 declared devices.
Catalogue references include 300006388121, 300009321511, 728272, 782110, 782155, 782207.
European nomenclature codes declared: Z1105018001,Z1105018002,Z1105018099, Z11030102, Z11050105, A018002, Z11050104, Z11050104,Z11050105.
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 |
Device-level evidence
| Devices with a numeric GTIN | 493 |
|---|---|
| Found in the U.S. device database | 433 |
| Share | 87.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
What it holds in Canada
| Licences on record | 106 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 72 |
| Class 3 devices | 34 |
| First licensed | 1999-11-10 |
Licence types: System (53), Single Device (30), Device Family (21), Device Group Family (1).
Licensed under: ADVANCED VISUALIZATION WORKSPACE, NM SUITE, SPECTRAL CT 7500 RT, AV VIEWER, AV CARDIOVASCULAR SUITE, INTEGRIS VASCULAR IMAGING SYSTEMS.
North American profile: Both markets. Philips Medical Systems Nederland B.V. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1135905-1 | supplemented | 2030-06-04 |
2243163CE01 | supplemented | 2030-07-01 |