Data / Medical devices / Hungary / QX World KFT
QX World KFT: FDA-registered device maker in Budapest, Hungary, 1 510(k) clearance
QX World KFT is registered with the FDA (registration 3010806878) in Budapest, Hungary. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 11, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010806878
- Address
- Tinodi utca 1-3 A. ep. IV. em. 93, Budapest, Hungary, 1095
- Owner or operator
- QX World KFT (10054119)
- Roles
- Manufacturer
- First device listed
- July 3, 2025
- Registered through
- 2027
- Brand names listed
- QUEX ED, QUEX S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Galvanic Skin Response Measurement | GZO | 2 | Manufacturer | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 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 |
|---|---|---|---|---|---|---|
| October 11, 2024 | K232779 | QUEX ED; QUEX S | OMC | Substantially Equivalent | Qx World, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Reduced- Montage Standard Electroencephalograph
- All makers of Device, Galvanic Skin Response Measurement
Updated October 11, 2024. 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.