# Caregen Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Caregen Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is Revofil Ultra | Revofil Ultra; product code is 78 M - - RE Solution, Sodium Hyaluronate | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use; date published is 04/15/2022; address is 270 Gongdan-Ro , Gunpo, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Caregen 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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 270 Gongdan-Ro , Gunpo, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 04/15/2022 _(verified: appears in the quote below)_
- **Product code:** 78 M - - RE Solution, Sodium Hyaluronate | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use _(verified: each item appears in the quote below)_
- **Product:** Revofil Ultra | Revofil Ultra _(verified: each item appears in the quote below)_

## What the source says

> Caregen Co., Ltd. Date Published : 04/15/2022 270 Gongdan-Ro , Gunpo, Gyeonggi KOREA (THE REPUBLIC OF) 78 M - - RE Solution, Sodium Hyaluronate Date Published: 04/15/2022 Desc: Revofil Ultra 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 04/15/2022 Desc: Revofil Ultra

## 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/).