QX World Kft. · 89-08 · HUNGARY
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
- 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 84 H - - CC Device, Biofeedback Date Published: 01/30/2020 Desc: Educator Biofeedback Device
— 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.