# MANDELAY KFT · 89-08 · HUNGARY — FDA import alert red lists: firms subject to detention without physical examination

For MANDELAY 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 The Quantum Xrroid Consciousness/Medical Interface System Unclassified; product code is 84 H - - CC Device, Biofeedback | 84 - - - -- Neurological; date published is 01/23/2019; address is Huba Utca 25-2 , Tokol, Pest HUNGARY, verified against its source on 2026-09-16.

- **Firm:** MANDELAY 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:** Huba Utca 25-2 , Tokol, Pest HUNGARY _(verified: appears in the quote below)_
- **Date published:** 01/23/2019 _(verified: appears in the quote below)_
- **Product code:** 84 H - - CC Device, Biofeedback | 84 - - - -- Neurological _(verified: each item appears in the quote below)_
- **Product:** The Quantum Xrroid Consciousness/Medical Interface System Unclassified _(verified: appears in the quote below)_
- **FDA notes:** Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/2008. | 6/28/2002 _(verified: each item appears in the quote below)_

## What the source says

> MANDELAY KFT Date Published : 01/23/2019 Huba Utca 25-2 , Tokol, Pest HUNGARY 84 H - - CC Device, Biofeedback Date Published: 05/06/2021 Notes: Electro Physiological Feedback Xrroid (EPFX) Quantum Xrroid (QXCl) QXCl Accessories Scientific Conscionesssness Interface Operations System (SCIO) Virtual Reality Imagery; Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy L.I.F.E System 1/4/2008. 84 - - - -- Neurological Date Published: 01/23/2019 Desc: The Quantum Xrroid Consciousness/Medical Interface System Unclassified Notes: 6/28/2002

## 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/).