Reference Source

Biorem S.R.L. · 89-08 · ITALY

For Biorem 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 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 2026-09-16.

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 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

accessdata.fda.gov, retrieved 2026-09-15

Source

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