Data / Medical devices / Netherlands / Medical Precision BV
Medical Precision BV: FDA-registered device maker in Zwolle Overijssel, Netherlands, 1 510(k) clearance
Medical Precision BV is registered with the FDA (registration 3021371724) in Zwolle Overijssel, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 10, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3021371724
- Address
- Menno van Coehoornsingel 2, Zwolle Overijssel, Netherlands, 8011 XA
- Owner or operator
- Medical Precision BV (10084372)
- Roles
- Specification developer
- First device listed
- February 17, 2022
- Registered through
- 2026
- Brand names listed
- Comfort Marker 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiation Therapy Marking Device | QRN | 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 |
|---|---|---|---|---|---|---|
| December 10, 2021 | DEN200041 | Comfort Marker 2.0. | QRN | Unknown | Medical Precision BV | accessdata.fda.gov |
Compare with other makers
Updated December 10, 2021. 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.