BRERA MEDICAL TECHNOLOGIES S.R.L. · 89-08 · ITALY
For BRERA MEDICAL TECHNOLOGIES S.R.L., import alert is 89-08; country is ITALY; 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 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 2026-09-30.
- Firm
- BRERA MEDICAL TECHNOLOGIES S.R.L. 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
- ITALY verified
- Address
- 84061 Loc. Terzerie, Z.I. , Ogliastro C. To (Sa) , Ogliastro, ITALY verified
- Date published
- 09/29/2009 verified
- Product code
- 79 G - - FE Brush, Dermabrasion verified
- Product
- SkinBella Crystal-Free Microdermabrasion System verified
- FDA notes
- Class I; Firm has no 510K for the product verified
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
— 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html