FDA Registration
Active
🇺🇸 United States
Portable Unit
Reg #: 1225677
·
FEI: 3001451453
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- UMI INTL.
- Registration Number
- 1225677
- FEI Number
- 3001451453
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 95 Hudson Ave. #3F10
- City
- Norwood
- State
- NJ
- ZIP
- 07648
- Country
- US
Regulatory Submissions
- 510(k) Number
- K070634
Owner / Operator
- Firm Name
- UMI INTL.
- Operator Number
- 9030079
- Address
- 95 Hudson Ave. #3F10
- City
- Norwood
- State
- NJ
- Postal Code
- 07648
- Country
- US
- Correspondent
- KWANG CHAE - JUNG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Mobile | IZL | Class 2 | Radiology | No | 2007-10-10 |
Proprietary Names
Portable Unit
Establishment Types
Repack or Relabel Medical Device