# FENIX GROUP SRL · 89-08 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For FENIX GROUP SRL · 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 Strada Lungofino 187 , Citta Sant Ange, ITALY, verified against its source on 2026-09-16.

- **Firm:** FENIX GROUP SRL _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Strada Lungofino 187 , Citta Sant Ange, ITALY _(verified: appears in the quote below)_
- **Date published:** 11/27/2023 _(verified: appears in the quote below)_
- **Product code:** 79 N - - UV Massager, Vaccuum, light induced heating | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Endospheres Device | Endospheres Device _(verified: each item appears in the quote below)_

## What the source says

> FENIX GROUP SRL Date Published : 11/27/2023 Strada Lungofino 187 , Citta Sant Ange, 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).