# BRERA MEDICAL TECHNOLOGIES S.R.L. · 89-08 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For BRERA MEDICAL TECHNOLOGIES S.R.L. · 89-08 · ITALY, 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 ITALY; product is SkinBella Crystal-Free Microdermabrasion System; product code is 79 G - - FE Brush, Dermabrasion; date published is 09/29/2009; address is 84061 Loc. Terzerie, Z.I. , Ogliastro C. To (Sa) , Ogliastro, ITALY, verified against its source on 2026-09-16.

- **Firm:** BRERA MEDICAL TECHNOLOGIES S.R.L. _(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:** ITALY _(verified: appears in the quote below)_
- **Address:** 84061 Loc. Terzerie, Z.I. , Ogliastro C. To (Sa) , Ogliastro, ITALY _(verified: appears in the quote below)_
- **Date published:** 09/29/2009 _(verified: appears in the quote below)_
- **Product code:** 79 G - - FE Brush, Dermabrasion _(verified: appears in the quote below)_
- **Product:** SkinBella Crystal-Free Microdermabrasion System _(verified: appears in the quote below)_
- **FDA notes:** Class I; Firm has no 510K for the product _(verified: appears in the quote below)_

## What the source says

> BRERA MEDICAL TECHNOLOGIES S.R.L. Date Published : 09/29/2009 84061 Loc. Terzerie, Z.I. , Ogliastro C. To (Sa) , Ogliastro, ITALY 79 G - - FE Brush, Dermabrasion Date Published: 09/29/2009 Desc: SkinBella Crystal-Free Microdermabrasion System Notes: Class I; Firm has no 510K for the product

## 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/).