Data / Medical devices / Netherlands / Medicalvr BV
Medicalvr BV: FDA-registered device maker in Nieuw-Vennep Noord-Holland, Netherlands, 1 510(k) clearance
Medicalvr BV is registered with the FDA (registration 3044737887) in Nieuw-Vennep Noord-Holland, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 29, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044737887
- Address
- Markkaweg 2, Nieuw-Vennep Noord-Holland, Netherlands, 2153 NB
- Owner or operator
- MedicalVR BV (10095305)
- Roles
- Manufacturer
- First device listed
- February 23, 2026
- Registered through
- 2026
- Brand names listed
- Surgical Reality Viewer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 29, 2026 | K252091 | Surgical Reality Viewer | QIH | Substantially Equivalent | Medicalvr B.V. | accessdata.fda.gov |
Compare with other makers
Updated January 29, 2026. 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.