FDA Registration
Active
🇰🇷 South Korea
SPECTRA WEARABLE
Reg #: 3011139154
·
FEI: 3011139154
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Uzinmedicare Co., Ltd.
- Registration Number
- 3011139154
- FEI Number
- 3011139154
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 56, Dongtansandan 5-gil
- City
- Hwaseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K220926
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 | 2022-12-21 |
Proprietary Names
SPECTRA WEARABLE
Establishment Types
Manufacture Medical Device