QX World Kft. · 89-08 · HUNGARY
For QX World Kft., import alert is 89-08; country is HUNGARY; 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)"; 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 2026-09-30.
- Firm
- QX World Kft. verified
- 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
- Address
- Tinodi Utca 1-3/A. Ep. Iv. Em. 93 , Budapest Ix, Budapest HUNGARY verified
- Date published
- 01/30/2020 verified
- Product code
- 84 H - - CC Device, Biofeedback verified
- Product
- Educator Biofeedback Device verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
84 H - - CC Device, Biofeedback Date Published: 01/30/2020 Desc: Educator Biofeedback Device
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.