Data / Medical devices / South Korea / Unimom Co.
Unimom Co.: FDA-registered device maker in Osan-si Gyeonggi, South Korea, 2 510(k) clearances
Unimom Co. is registered with the FDA (registration 3012298445) in Osan-si Gyeonggi, South Korea. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 30, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012298445
- Address
- 110-19, Gajangsaneopseobuk-Ro, Osan-si Gyeonggi, South Korea, 18102
- Owner or operator
- Unimom Co. (10053086)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 30, 2016
- Registered through
- 2026
- Brand names listed
- MEZZO# (PREGMUM BASICS, SANTEBEBE, Mii, HYGEIA,SANITY EASY-COMFORT), Opera, Opera eco, Unimom Nipple (NIPPLE, FEEDER)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | PWA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Nipple, Lambs Feeding | FNN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Shield, Nipple | HFS | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 30, 2019 | K190810 | OPERA, OPERA eco | HGX | Substantially Equivalent | Unimom.Co | accessdata.fda.gov |
| August 6, 2018 | K180075 | MINUET LCD, MINUET LCD eco | HGX | Substantially Equivalent | Unimom.Co | accessdata.fda.gov |
Compare with other makers
- All makers of Shield, Nipple
- All makers of Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
- All makers of Pump, Breast, Powered
- All makers of Nipple, Lambs Feeding
- All makers of Pump, Breast, Non-Powered
Updated August 30, 2019. 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.