FDA Registration
Active
🇰🇷 South Korea
M.I.One Co.,Ltd.
Reg #: 3016245408
·
FEI: 3016245408
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- M.I.One Co.,Ltd.
- Registration Number
- 3016245408
- FEI Number
- 3016245408
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 233, Usan-ro
- City
- Wonju-si Gangwon
- Country
- KR
Owner / Operator
- Firm Name
- M.I.One Co.,Ltd.
- Operator Number
- 10062106
- Address
- 233, Usan-ro
- City
- Wonju-si
- State
- Gangwon
- Postal Code
- 26335
- Country
- KR
- Correspondent
- DooHwan Lee
US Agent
- Business Name
- FDAbasics
- Contact Name
- Emily Matorin
- Address
- 1 Prospect Park W Apt 4d
- City
- Brooklyn
- State
- NY
- ZIP
- 11215
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2019-12-19 |
| Camera, Still, Surgical | FTT | Class 1 | General, Plastic Surgery | No | 2019-12-19 |
| Table, Examination, Medical, Powered | LGX | Class 1 | General, Plastic Surgery | No | 2019-12-19 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 2019-12-19 |
| Unit, Examining/Treatment, Ent | ETF | Class 1 | Ear, Nose, Throat | No | 2019-12-19 |
Proprietary Names
Insight-IL
Insight-I
Insight-I+
CW-2000, LED-Z1000, CCU-2200, CH-2200, CG-2200
IC-3000
Insight-u+
Insight-u
IU-3000
Establishment Types
Manufacture Medical Device