FDA Registration
Active
🇺🇸 United States
Digital PD Ruler
Reg #: 2518410
·
FEI: 2518410
·
Expires 2025
Products
1
Proprietary Names
3
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 |
|---|---|---|---|---|---|
| Pupillometer, Manual | HLH | Class 1 | Ophthalmic | No | 2023-06-28 |
Proprietary Names
Digital PD Ruler
Accurate Pupil Tester (APT)
Digital Pupilometer with Vertex Distance
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device