Data / Medical devices / Pump, Breast, Powered / South Korea
FDA-registered makers of Pump, Breast, Powered in South Korea: 6 establishments
6 establishments in South Korea are registered with the FDA to make Pump, Breast, Powered (product code HGX). 6 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
- Pump, Breast, Powered
- Product code
- HGX
- Country
- South Korea
Makers of Pump, Breast, Powered in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Uzinmedicare Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 11 | April 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cimilre Co., Ltd. | Cheonan-si Chungnam, South Korea | Manufacturer | 3 | August 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Imani | Yongin Gyeonggi, South Korea | Manufacturer | 3 | March 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bistos co., ltd. | Yongin-si Gyeonggi, South Korea | Complaint file establishment, Manufacturer | 2 | September 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Unimom Co. | Osan-si Gyeonggi, South Korea | Exporter to the US, Manufacturer | 2 | August 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| Haenim CO.,LTD. | Seo-gu Incheon, South Korea | Manufacturer | 1 | June 29, 2022 | 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.