FDA Registration
Active
🇺🇸 United States
HighLife Medical
Reg #: 3010410494
·
FEI: 3010410494
·
Expires 2026
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- HighLife Medical
- Registration Number
- 3010410494
- FEI Number
- 3010410494
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12 Goodyear Ste 125
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Owner / Operator
- Firm Name
- HighLife Medical
- Operator Number
- 10050888
- Address
- 12 Goodyear, Suite 125
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Eric S Simon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Replacement Heart-Valve | DYE | Class 3 | Cardiovascular | No | 2016-01-13 |
Proprietary Names
Valve Loading Tool
Loop Placement Catheter
SAI Delivery Catheter
Sub-Annular Implant
Trans-Septal Delivery Catheter
28mm Mitral Heart Valve, LAV
28mm Mitral Heart Valve
Establishment Types
Manufacture Device in the United States for Export Only