Data / Medical devices / Elastomer, Silicone, For Scar Management / South Korea
FDA-registered makers of Elastomer, Silicone, For Scar Management in South Korea: 8 establishments
8 establishments in South Korea are registered with the FDA to make Elastomer, Silicone, For Scar Management (product code MDA). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Elastomer, Silicone, For Scar Management
- Product code
- MDA
- Country
- South Korea
Makers of Elastomer, Silicone, For Scar Management in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| CG Bio Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cellartgen Osong Plant | Cheongju-si, Chungcheongbuk-do, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Everaid Co., Ltd. | YANGSAN-SI Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genewel Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hans Biomed Corp. | Daejeon, South Korea | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healthy Hub Co., Ltd. | Seoul, South Korea | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| T&L Co., Ltd. Anseong Factory | ANSEONG-CITY Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wonbiogen Co., Ltd. | Gumi-si Gyeongbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.