FDA Registration
Active
🇺🇸 United States
AdaptDx, Inc
Reg #: 3016500342
·
FEI: 3016500342
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- AdaptDx, Inc
- Registration Number
- 3016500342
- FEI Number
- 3016500342
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1000 Kreider Drive, STE 700
- City
- Middletown
- State
- PA
- ZIP
- 17057
- Country
- US
Owner / Operator
- Firm Name
- OpZira, Inc.
- Operator Number
- 10093974
- Address
- 1000 Kreider Drive, STE 700
- City
- Middletown
- State
- PA
- Postal Code
- 17057
- Country
- US
- Correspondent
- Lori A Holder
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation | OUM | Class 1 | Ophthalmic | No | 2025-08-27 |
Proprietary Names
AdaptDx Pro
AdaptDx
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device