Rollz International
NL-MF-000002978 · Netherlands · Delft
Rollz International is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 46 |
|---|
Most frequent device types declared: 5010RF0010, Rollz Motion Rollator.
Among these devices, 4 are declared active.
Devices declared under this manufacturer
- Rollz Air Medium Green
- Rollz Air Medium Wide Green
- Rollz Air Small Black
- Rollz Flex
- Rollz Flow Granite black Wide
- Rollz Flow Granite black regular
- Rollz Flow Ocean blue regular
- Rollz Flow Ocean blue small
- Rollz Flow Ocean blue wide
- Rollz Motion 2.1
- Rollz Motion Electric conversion kit
- Rollz Motion Performance
Showing 12 of 46 declared devices.
Catalogue references include 1010RM0006, 1020RE0001, 2010RM0030, 2016RM0001, 3010RF0012, 4010RA0011.
European nomenclature codes declared: Y120609, Y120609,Y122103, Y122410, Y120609,Y122127.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ROLLZ INTERNATIONAL BV (NL) · FDA 3010547267 |
| Devices in EUDAMED | 46 |
| Country of registration | Netherlands |
Device-level evidence
| Devices with a numeric GTIN | 46 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Rollz International is registered in the United States but was not found in the Canadian register.