# QX World Kft. · 89-08 · HUNGARY — FDA import alert red lists: firms subject to detention without physical examination

For QX World Kft. · 89-08 · HUNGARY, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is HUNGARY; product is Educator Biofeedback Device; product code is 84 H - - CC Device, Biofeedback; date published is 01/30/2020; address is Tinodi Utca 1-3/A. Ep. Iv. Em. 93 , Budapest Ix, Budapest HUNGARY, verified against its source on 2026-09-16.

- **Firm:** QX World Kft. _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** HUNGARY _(verified: appears in the quote below)_
- **Address:** Tinodi Utca 1-3/A. Ep. Iv. Em. 93 , Budapest Ix, Budapest HUNGARY _(verified: appears in the quote below)_
- **Date published:** 01/30/2020 _(verified: appears in the quote below)_
- **Product code:** 84 H - - CC Device, Biofeedback _(verified: appears in the quote below)_
- **Product:** Educator Biofeedback Device _(verified: appears in the quote below)_

## What the source says

> QX World Kft. Date Published : 01/30/2020 Tinodi Utca 1-3/A. Ep. Iv. Em. 93 , Budapest Ix, Budapest HUNGARY 84 H - - CC Device, Biofeedback Date Published: 01/30/2020 Desc: Educator Biofeedback Device

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).