Caregen Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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
- Address
- 270 Gongdan-Ro , Gunpo, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 04/15/2022 verified
- Product code
- 78 M - - RE Solution, Sodium Hyaluronate | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use each item verified
- Product
- Revofil Ultra | Revofil Ultra each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.