Caregen Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Caregen Co., Ltd., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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)"; 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 2026-09-30.
- 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)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html