FDA Registration
Active
🇺🇸 United States
Vision Therapy Kit
Reg #: 2518410
·
FEI: 2518410
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- GULDEN OPHTHALMICS
- Registration Number
- 2518410
- FEI Number
- 2518410
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 225 CADWALADER AVE.
- City
- Elkins Park
- State
- PA
- ZIP
- 19027
- Country
- US
Owner / Operator
- Firm Name
- GULDEN OPHTHALMICS INC
- Operator Number
- 2518410
- Address
- 225 CADWALADER AVE., --
- City
- Elkins Park
- State
- PA
- Postal Code
- 19027
- Country
- US
- Correspondent
- SEAN T COCKLEY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 1993-11-10 |
Proprietary Names
Vision Therapy Kit
Pediatric Screening Kit
Sloan Letter Acuity Chart (3 meter)
Wormington Card
Pediatric CPAC
Eger Equivalent Near Card
Adult Near Contrast Test Booklet
Modified Thorington Test Card
LEA Symbols Acuity Chart (3 meter)
Near Point Card (2pk)
Phoropter Roto Chart
Accommodation Cards (5pk)
Adult Screening Kit
Eye Alignment Near Card
Sloan Letter Folding Chart (3 meter)
Neumueller Card
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device