# Jilin Folialux Bio-Tech Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Jilin Folialux Bio-Tech Co., Ltd · 89-08 · CHINA, 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 CHINA; product is Poly L-Lactic Acid; product code is 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use; date published is 09/03/2024; address is FAW-Sihuan Xufa Workshop Building B1B2 , Changchun, Jilin CHINA, verified against its source on 2026-09-16.

- **Firm:** Jilin Folialux Bio-Tech Co., Ltd _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** FAW-Sihuan Xufa Workshop Building B1B2 , Changchun, Jilin CHINA _(verified: appears in the quote below)_
- **Date published:** 09/03/2024 _(verified: appears in the quote below)_
- **Product code:** 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use _(verified: appears in the quote below)_
- **Product:** Poly L-Lactic Acid _(verified: appears in the quote below)_

## What the source says

> Jilin Folialux Bio-Tech Co., Ltd Date Published : 09/03/2024 FAW-Sihuan Xufa Workshop Building B1B2 , Changchun, Jilin CHINA 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 09/03/2024 Desc: Poly L-Lactic Acid

## 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/).