# Teoxane S.A. · 89-08 · SWITZERLAND — FDA import alert red lists: firms subject to detention without physical examination

For Teoxane S.A. · 89-08 · SWITZERLAND, 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 SWITZERLAND; product is TEOSYAL PureSense Deep Lines | TEOSYAL PureSense Ultra Deep | TEOSYAL PureSense Global Action; product code is 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use; date published is 03/08/2013; address is Rue De Lyon 105 , Geneva, Geneva SWITZERLAND, verified against its source on 2026-09-16.

- **Firm:** Teoxane S.A. _(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:** SWITZERLAND _(verified: appears in the quote below)_
- **Address:** Rue De Lyon 105 , Geneva, Geneva SWITZERLAND _(verified: appears in the quote below)_
- **Date published:** 03/08/2013 _(verified: appears in the quote below)_
- **Product code:** 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use _(verified: each item appears in the quote below)_
- **Product:** TEOSYAL PureSense Deep Lines | TEOSYAL PureSense Ultra Deep | TEOSYAL PureSense Global Action _(verified: each item appears in the quote below)_
- **FDA notes:** class II; | class II; | class II; _(verified: each item appears in the quote below)_

## What the source says

> Teoxane S.A. Date Published : 03/08/2013 Rue De Lyon 105 , Geneva, Geneva SWITZERLAND 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 02/10/2021 Desc: TEOSYAL PureSense Deep Lines Notes: class II; 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 02/10/2021 Desc: TEOSYAL PureSense Ultra Deep Notes: class II; 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 02/10/2021 Desc: TEOSYAL PureSense Global Action Notes: class II;

## 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/).