FDA Registration
Active
🇰🇷 South Korea
Uzinmedicare Co., Ltd.
Reg #: 3011139154
·
FEI: 3011139154
·
Expires 2026
Products
4
Proprietary Names
23
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Uzinmedicare Co., Ltd.
- Registration Number
- 3011139154
- FEI Number
- 3011139154
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 54, 56, 60 Dongtansandan 5-gil
- City
- Hwaseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K210124
Owner / Operator
- Firm Name
- Uzinmedicare Co., Ltd.
- Operator Number
- 10033747
- Address
- 56, Dongtansandan 5-gil
- City
- Hwaseong-si
- State
- Gyeonggi
- Postal Code
- 18487
- Country
- KR
- Correspondent
- Byungwook Min
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2021-12-16 |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile | MCF | Class 1 | Dental | No | 2017-08-18 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2017-04-27 |
| Breast Pump Kit | OHH | Class 2 | Obstetrics/Gynecology | No | 2026-05-20 |
Proprietary Names
Spectra SG Portable
UV-Sterilizers (for baby bottle), Model : Spectra
Model : Spectra
UV-Sterilizers (for baby bottle)
Spectra Q
Spectra Handy Plus
Spectra wide manual pump
Spectra Handy
Spectra Wearable2
Spectra S2 Pro
Spectra S1 Pro
Spectra Platinum
SPECTRA WEARABLE
Spectra 9plus
Spectra S1 Plus
Spectra S2 Plus
Spectra Dew300
Clinicare Dew400
Spectra Dew350
Spectra Handsfree Breast Shield Set 2
Spectra S3 Pro
Spectra S3 Plus
Spectra Synergy Gold
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility