Data / Medical devices / Dressing, Wound, Hydrogel Without Drug And/Or Biologic / South Korea
FDA-registered makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic in South Korea: 14 establishments
14 establishments in South Korea are registered with the FDA to make Dressing, Wound, Hydrogel Without Drug And/Or Biologic (product code NAE). 1 has 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
- Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- Product code
- NAE
- Country
- South Korea
Makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hydrochem Co., Ltd | Gangeung-Si Gangwon, South Korea | Manufacturer | 1 | August 23, 1995 | 0 | 0 | 0 | api.fda.gov |
| BK Medicare Co., Ltd. | Yangsan Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Daeun Medical | Bucheon Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dmed | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Doum Corporation | Dong-gu Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DSH Medical Co., Ltd. | Siheung-si Gyeonggi, 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 | |
| Incore Co., Ltd. | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MANTIZ Co.,Ltd. | Daegu, South Korea | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NICOMEDICAL Co., Ltd. | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nurimedics Co., Ltd | Gimpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthotech Co., Ltd. | Dong-Gu Daegu, South Korea | Manufacturer | 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.