FENIX GROUP S.R.L. · 89-08 · ITALY
For FENIX GROUP 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 Endospheres Device | Endospheres Device; product code is 79 N - - UV Massager, Vaccuum, light induced heating | 89 I - - SA Massager, Therapeutic, Electric; date published is 11/27/2023; address is Via Agostinone 9 , Montesilvano, Pescara ITALY, verified against its source on 2026-09-16.
- Firm
- FENIX GROUP 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 Agostinone 9 , Montesilvano, Pescara ITALY verified
- Date published
- 11/27/2023 verified
- Product code
- 79 N - - UV Massager, Vaccuum, light induced heating | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Endospheres Device | Endospheres Device each item verified
What the source says
FENIX GROUP S.R.L. Date Published : 11/27/2023 Via Agostinone 9 , Montesilvano, Pescara ITALY 79 N - - UV Massager, Vaccuum, light induced heating Date Published: 11/27/2023 Desc: Endospheres Device 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/27/2023 Desc: Endospheres Device
— 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.