FDA Registration
Active
🇺🇸 United States
IRIS USA INC
Reg #: 3002813051
·
FEI: 3002813051
·
Expires 2026
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IRIS USA INC
- Registration Number
- 3002813051
- FEI Number
- 3002813051
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11111 80th Ave
- City
- Pleasant Prairie
- State
- WI
- ZIP
- 53158
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230380
Owner / Operator
- Firm Name
- IRIS USA INC
- Operator Number
- 10093997
- Address
- 11111 80 th ave
- City
- Pleasant Prairie
- State
- WI
- Postal Code
- 53158
- Country
- US
- Correspondent
- Jimmie Henderson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2025-09-05 |
Establishment Types
Manufacture Medical Device