FDA Registration
Active
🇺🇸 United States
9941 Ultralite
Reg #: 1063300
·
FEI: 1000488948
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- PROTECH LEADED EYEWEAR, INC.
- Registration Number
- 1063300
- FEI Number
- 1000488948
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7960 Central Industrial Drive, Ste 125
- City
- West Palm Beach
- State
- FL
- ZIP
- 33404
- Country
- US
Owner / Operator
- Firm Name
- Protech Leaded Eyewear, Inc.
- Operator Number
- 10025412
- Address
- 7960 Central Industrial Drive, Ste 125
- City
- West Palm Beach
- State
- FL
- Postal Code
- 33404
- Country
- US
- Correspondent
- Evin Lalan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shield, Eye, Radiological | IWS | Class 1 | Radiology | No | 2018-12-21 |
Proprietary Names
9941 Ultralite
53 Wrap
Face Shield
99 Alumilite
9935 Ultralite
99 Ultralite
Astroflex
Proguard Leader
Fit Over
Comet
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device