FDA Registration
Active
🇰🇷 South Korea
3D ONS, INC.
Reg #: 3023266032
·
FEI: 3023266032
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- 3D ONS, INC.
- Registration Number
- 3023266032
- FEI Number
- 3023266032
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18, Eonju-ro 171-gil
- City
- Gangnam-gu Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K221000
Owner / Operator
- Firm Name
- 3D ONS, Inc.
- Operator Number
- 10085447
- Address
- 18, Eonju-ro 171-gil
- City
- Gangnam-gu
- State
- Seoul
- Postal Code
- 06023
- Country
- KR
- Correspondent
- HeonJae Cho
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 |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2022-06-19 |
Proprietary Names
ON3D
Establishment Types
Manufacture Medical Device