Rovers Medical Devices B.V.
NL-MF-000001553 · Netherlands · Oss
Rovers Medical Devices B.V. is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 31 |
|---|
Among these devices, 18 are declared sterile.
Devices declared under this manufacturer
- Rovers® Anex® Brush
- Rovers® Cervex-Brush®
- Rovers® Cervex-Brush® Combi
- Rovers® Cervex-Brush® Combi RT
- Rovers® Cervex-Brush® RT
- Rovers® Cervex-brush® Combi
- Rovers® EndoCervex-Brush®
- Rovers® EndoCervex-Brush® RT
- Rovers® EndoCervex-Brush®-S
- Rovers® EndoCervex-Brush®-S RT
- Rovers® Evalyn® Brush
- Rovers® Orcellex® Brush RT
Showing 12 of 31 declared devices.
Catalogue references include 380100311, 380100324, 380100731, 380100740, 380101-030, 380300331.
European nomenclature codes declared: A99, A99,U089002, A99,U089002,U09030301.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ROVERS MEDICAL DEVICES B.V. (NL) · FDA 9680221 |
| Devices in EUDAMED | 31 |
| Country of registration | Netherlands |
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| Found in the U.S. device database | 29 |
| Share | 93.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ROVERS MEDICAL DEVICES B.V. |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2000-10-20 |
Licence types: Device Family (1), Single Device (1).
Licensed under: CELL SAMPLING DEVICES/CYTOLOGY BRUSHES - POLYE, CELL SAMPLING DEVICE/CYTOLOGY BRUSHES - POLYPR.
North American profile: Both markets. Rovers Medical Devices B.V. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
44911220665 | issued | 2029-05-16 |