FDA Registration
Active
🇺🇸 United States
BC4
Reg #: 3003703880
·
FEI: 3003703880
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HIGI SH LLC
- Registration Number
- 3003703880
- FEI Number
- 3003703880
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100 South Wacker Drive , Suite 1600
- City
- Chicago
- State
- IL
- ZIP
- 60606
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101807
Owner / Operator
- Firm Name
- higi SH LLC
- Operator Number
- 10032072
- Address
- 100 South Wacker Drive, Suite 1600
- City
- Chicago
- State
- IL
- Postal Code
- 60606
- Country
- US
- Correspondent
- Amy S Halik
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Body Composition | MNW | Class 2 | Cardiovascular | No | 2014-12-03 |
Proprietary Names
BC4
Body Composition Analyzer
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility