Reference Source

Biorem S.R.L. · 89-08 · ITALY

For Biorem 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 code is 79 G - - EX Powered laser surgical instruments | 79 G - - FD Dermatome; date published is 09/16/2009; address is Via Francesco Angrisani 18A , Agropoli, Salerno ITALY, verified against its source on 2026-09-30.

Firm
Biorem 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
Via Francesco Angrisani 18A , Agropoli, Salerno ITALY verified
Date published
09/16/2009 verified
Product code
79 G - - EX Powered laser surgical instruments | 79 G - - FD Dermatome each item verified
FDA notes
SkinMaster MicroDermabrasion Product 1/2/2002 | SkinMaster MicroDermabrasion Product 1/2/2002 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Biorem S.R.L. Date Published : 09/16/2009 Via Francesco Angrisani 18A , Agropoli, Salerno 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 and FDA notes

79 G - - EX Powered laser surgical instruments Date Published: 09/16/2009 Notes: SkinMaster MicroDermabrasion Product 1/2/2002 79 G - - FD Dermatome Date Published: 09/16/2009 Notes: SkinMaster MicroDermabrasion Product 1/2/2002

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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.