Data / Medical devices / Netherlands / Qlrad
Qlrad: FDA-registered device maker in Almere Flevoland, Netherlands, 2 510(k) clearances
Qlrad is registered with the FDA (registration 3006948745) in Almere Flevoland, Netherlands. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 13, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006948745
- Address
- Damsluisweg 6, Almere Flevoland, Netherlands, 1332 EC
- Owner or operator
- QLRAD International Ltd. (10025073)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- August 29, 2013
- Registered through
- 2026
- Brand names listed
- Endorectal balloon, Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US | accessdata.fda.gov |
| Prostate Immobilizer Rectal Balloon | PCT | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US | 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 13, 2018 | K180478 | RectalPro 75 Endorectal Balloon | PCT | Substantially Equivalent | Qlrad International , Ltd. | accessdata.fda.gov |
| December 14, 2011 | K112057 | KDL SYRINGES AND NEEDLE | FMF | Substantially Equivalent | Shanghai Kindly Enterprise Dev. Group Co., | accessdata.fda.gov |
Compare with other makers
- All makers of Prostate Immobilizer Rectal Balloon
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
Updated November 13, 2018. 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.