FDA Registration
Active
🇰🇷 South Korea
UNIMOM CO.
Reg #: 3012298445
·
FEI: 3012298445
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- UNIMOM CO.
- Registration Number
- 3012298445
- FEI Number
- 3012298445
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 110-19, GAJANGSANEOPSEOBUK-RO
- City
- Osan-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K190810
Owner / Operator
- Firm Name
- Unimom Co.
- Operator Number
- 10053086
- Address
- 110-19, Gajangsaneopseobuk-ro
- City
- Osan-si
- State
- Gyeonggi
- Postal Code
- 18102
- Country
- KR
- Correspondent
- Sang Hyun Hong
US Agent
- Business Name
- KMC USA, Inc
- Contact Name
- Jung Ryun Ahn
- Address
- 115 East 34th street, 13J
- City
- New York
- State
- NY
- ZIP
- 10016
- Country
- US
- [email protected]
- Phone
- 646 3576058
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | PWA | Class 1 | Obstetrics/Gynecology | No | 2018-12-12 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2019-09-23 |
| Shield, Nipple | HFS | Class 1 | General Hospital | No | 2018-01-25 |
| Nipple, Lambs Feeding | FNN | Class 1 | General Hospital | No | 2018-02-01 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2016-10-30 |
Proprietary Names
Opera eco
Opera
Unimom Nipple (NIPPLE, FEEDER)
MEZZO# (PREGMUM BASICS, SANTEBEBE, Mii, HYGEIA,SANITY EASY-COMFORT)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device