Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017657497

FEI Number

3017657497

Entity Name

HERU, INC.

City/State/Country

Miami, FL, US

Establishment Address

201 S Biscayne Blvd Suite 2866, Miami, FL 33131, US

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Heru, Inc. (Owner Number: 10079219)

Owner / Operator Contact Address

201 S Biscayne Blvd. Suite 2866, Miami, FL 33131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIT	Tester, Color Vision	Ophthalmic	Class 1	886.1170	2022-08-15
HJQ	Stereoscope, Ac-Powered	Ophthalmic	Class 1	886.1870	2023-03-30
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2022-08-15
OUM	Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation	Ophthalmic	Class 1	886.1050	2022-08-15
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2025-07-01
HPT	Perimeter, Automatic, Ac-Powered	Ophthalmic	Class 1	886.1605	2020-11-24
HLG	Pupillometer, Ac-Powered	Ophthalmic	Class 1	886.1700	2023-03-28
QTO	Digital Visual Acuity Test	Ophthalmic	Class 1	886.1150	2023-03-28

Official Correspondent

Mohamed Abou Shousha

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Heru, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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3006550126	SPEEDWAY	India Delhi, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017657497. Last updated year: 2026. Please use registration number 3017657497 when referencing this establishment in official correspondence.