Smie Srl · 89-08 · ITALY
For Smie Srl, 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 85 M - - GI Aspirator, Ultrasonic; date published is 09/16/2009; address is Via Francesco Negri 15 , Casale Monferrato, Alexandria ITALY, verified against its source on 2026-09-30.
- Firm
- Smie Srl 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 Negri 15 , Casale Monferrato, Alexandria ITALY verified
- Date published
- 09/16/2009 verified
- Product code
- 85 M - - GI Aspirator, Ultrasonic verified
- FDA notes
- Sculpture Ultrasonic Aspiration Device (Sculture Ultrasound Wave Liposculpture) 1/22/1999 verified
What the source says
Smie Srl Date Published : 09/16/2009 Via Francesco Negri 15 , Casale Monferrato, Alexandria 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
85 M - - GI Aspirator, Ultrasonic Date Published: 09/16/2009 Notes: Sculpture Ultrasonic Aspiration Device (Sculture Ultrasound Wave Liposculpture) 1/22/1999
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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.