Data / Medical devices / Netherlands / Rollz International BV
Rollz International BV: FDA-registered device maker in Delft Zuid-Holland, Netherlands, 1 510(k) clearance
Rollz International BV is registered with the FDA (registration 3010547267) in Delft Zuid-Holland, Netherlands. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010547267
- Address
- Rotterdamseweg 402M, Delft Zuid-Holland, Netherlands, 2629 HH
- Owner or operator
- Rollz International BV (10045231)
- Roles
- Specification developer
- First device listed
- October 29, 2013
- Registered through
- 2026
- Brand names listed
- Rollz Air, Rollz Flex, Rollz Flow, Rollz Motion, Rollz Motion Electric, Rollz Wheelchair Accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Specification developer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Specification developer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 7, 2025 | K250819 | Electric Wheelchair (Rollz Motion Electric 2M) | ITI | Substantially Equivalent | Rollz International BV | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Wheelchair
- All makers of Walker, Mechanical
- All makers of Wheelchair, Powered
Updated November 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.