FDA Registration
Active
🇰🇷 South Korea
IMANI
Reg #: 3018159965
·
FEI: 3018159965
·
Expires 2026
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IMANI
- Registration Number
- 3018159965
- FEI Number
- 3018159965
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 147, Hwasan-ro, Idong-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea.
- City
- Yongin Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K222573
Owner / Operator
- Firm Name
- imani
- Operator Number
- 10080975
- Address
- 147, Hwasan-ro, Idong-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea.
- City
- Yongin
- State
- Gyeonggi
- Postal Code
- 17135
- Country
- KR
- Correspondent
- Hwang Hyosoon
US Agent
- Business Name
- Milk Matters Collective LLC
- Contact Name
- Jonathan C Gillan
- Address
- 306 E 15th Street, Tempe, AZ 85281
- City
- Tempe
- State
- AZ
- ZIP
- 85281
- Country
- US
- [email protected]
- Phone
- 602 3901596
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2023-03-06 |
Proprietary Names
imani i2Plus, imani i2Plus Pro
imani i1, imani i1Plus
imani i2
Establishment Types
Manufacture Medical Device