Data / Medical devices / Radiation Therapy Marking Device
Radiation Therapy Marking Device (QRN): 4 FDA-registered makers in 1 country
4 establishments in 1 country are registered with the FDA to make Radiation Therapy Marking Device (product code QRN, Class 2, 21 CFR 892.5785). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on March 30, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QRN
- Device class
- 2
- Regulation
- 892.5785
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| Netherlands | 4 |
Makers of Radiation Therapy Marking Device
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medical Precision BV | Zwolle Overijssel, Netherlands | Specification developer | 1 | December 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| Promolding BV | Den Haag Zuid-Holland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unitron Group BV | IJzendijke Zeeland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Valuepack B.V. | Nijmegen Gelderland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 30, 2023. 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.