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

For Erxer Bt. · 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 code is 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat; date published is 09/16/2009; address is Napsugar utca 21 , Csomad, Pest HUNGARY, verified against its source on 2026-09-16.

- **Firm:** Erxer Bt. _(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:** Napsugar utca 21 , Csomad, Pest HUNGARY _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat _(verified: appears in the quote below)_
- **FDA notes:** Pollogen Regan/Pollegen MJ 5/12/2009 Shipper for Pollegen Ltd. _(verified: appears in the quote below)_

## What the source says

> Erxer Bt. Date Published : 09/16/2009 Napsugar utca 21 , Csomad, Pest HUNGARY 89 I - - MJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat Date Published: 09/16/2009 Notes: Pollogen Regan/Pollegen MJ 5/12/2009 Shipper for Pollegen Ltd.

## 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/).