# Nouvag Ag · 89-08 · SWITZERLAND — FDA import alert red lists: firms subject to detention without physical examination

For Nouvag Ag · 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 Liposuction Machine; LipoSurg | Liposuction Machine; LipoSurg | Liposuction Machine; LipoSurg; product code is 79 J - - CX Apparatus, Suction, Ward Use, Portable, Ac-Powered | 79 M - - UU System, Suction, Lipoplasty | 80 F - - RN Pump, Infusion; date published is 08/14/2019; address is St. Gallerstrasse 23-25 , Goldach, St. Gallen SWITZERLAND, verified against its source on 2026-09-16.

- **Firm:** Nouvag Ag _(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:** St. Gallerstrasse 23-25 , Goldach, St. Gallen SWITZERLAND _(verified: appears in the quote below)_
- **Date published:** 08/14/2019 _(verified: appears in the quote below)_
- **Product code:** 79 J - - CX Apparatus, Suction, Ward Use, Portable, Ac-Powered | 79 M - - UU System, Suction, Lipoplasty | 80 F - - RN Pump, Infusion _(verified: each item appears in the quote below)_
- **Product:** Liposuction Machine; LipoSurg | Liposuction Machine; LipoSurg | Liposuction Machine; LipoSurg _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device, requires 510(k), or de novo application. | Class II device, requires 510(k), or de novo application. | Class II device, requires 510(k), or de novo application. _(verified: each item appears in the quote below)_

## What the source says

> Nouvag Ag Date Published : 08/14/2019 St. Gallerstrasse 23-25 , Goldach, St. Gallen SWITZERLAND 79 J - - CX Apparatus, Suction, Ward Use, Portable, Ac-Powered Date Published: 11/21/2024 Desc: Liposuction Machine; LipoSurg Notes: Class II device, requires 510(k), or de novo application. 79 M - - UU System, Suction, Lipoplasty Date Published: 11/21/2024 Desc: Liposuction Machine; LipoSurg Notes: Class II device, requires 510(k), or de novo application. 80 F - - RN Pump, Infusion Date Published: 11/21/2024 Desc: Liposuction Machine; LipoSurg Notes: Class II device, requires 510(k), or de novo application.

## 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/).