FDA Registration
Active
🇺🇸 United States
HERU, INC.
Reg #: 3017657497
·
FEI: 3017657497
·
Expires 2026
Products
9
Proprietary Names
8
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- HERU, INC.
- Registration Number
- 3017657497
- FEI Number
- 3017657497
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 201 S Biscayne Blvd Suite 2866
- City
- Miami
- State
- FL
- ZIP
- 33131
- Country
- US
Owner / Operator
- Firm Name
- Heru, Inc.
- Operator Number
- 10079219
- Address
- 201 S Biscayne Blvd. Suite 2866
- City
- Miami
- State
- FL
- Postal Code
- 33131
- Country
- US
- Correspondent
- Mohamed Abou Shousha
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tester, Color Vision | HIT | Class 1 | Ophthalmic | No | 2022-08-15 |
| Stereoscope, Ac-Powered | HJQ | Class 1 | Ophthalmic | No | 2023-03-30 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2022-08-15 |
| Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation | OUM | Class 1 | Ophthalmic | No | 2022-08-15 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2025-07-01 |
| Perimeter, Automatic, Ac-Powered | HPT | Class 1 | Ophthalmic | No | 2020-11-24 |
| Pupillometer, Ac-Powered | HLG | Class 1 | Ophthalmic | No | 2023-03-28 |
| Digital Visual Acuity Test | QTO | Class 1 | Ophthalmic | No | 2023-03-28 |
| Test, Spectacle Dissociation, Ac-Powered (Lancaster) | HJS | Class 1 | Ophthalmic | No | 2023-03-30 |
Proprietary Names
Heru Color Vision Test D-15
Heru Color Vision Test Ishihara
Heru Cover Test
Heru Contrast Sensitivity
Heru Dark Adaptation
Heru Refract
Heru Visual Field
Heru Eye Motility
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198