FDA Registration
Active
🇺🇸 United States
WINFAME USA INC.
Reg #: 3005548740
·
FEI: 3005548740
·
Expires 2026
Products
9
Proprietary Names
4
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- WINFAME USA INC.
- Registration Number
- 3005548740
- FEI Number
- 3005548740
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 710 S. Myrtle Ave, STE 189
- City
- Monrovia
- State
- CA
- ZIP
- 91016
- Country
- US
Owner / Operator
- Firm Name
- WINFAME USA INC.
- Operator Number
- 9083124
- Address
- 5548 Welland Ave, Ste F
- City
- Temple City
- State
- CA
- Postal Code
- 91780
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2008-03-19 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2008-03-19 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2023-01-18 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2008-03-19 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2008-03-19 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2008-03-19 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2008-03-19 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2008-03-19 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2008-03-19 |
Proprietary Names
WF OPH CANNULA
WF FORCEPTS
Winfame Scleral Dejpressor double ends
WFPST TRAYS
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility