CG Bio Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)

For CG Bio 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 MAYFILL Volume Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | MAYFILL Deep Cross-linked Hyaluronic Acid | MAYFILL Volume Cross-linked Hyaluronic Acid | MAYFILL Deep Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid; product code is 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 01/13/2025; address is 29 Jeyakdanji-Ro , Hyangnam-Eup , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.

What the source says

CG Bio Co., Ltd. Date Published : 01/13/2025 29 Jeyakdanji-Ro , Hyangnam-Eup , Hwaseong, Gyeonggi KOREA (THE REPUBLIC OF)

— accessdata.fda.gov, retrieved 2026-09-22

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.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.