Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000261180

FEI Number

1000261180

Entity Name

GENTEX CORPORATION

City/State/Country

Zeeland, MI, US

Establishment Address

600 North Centennial Street, Zeeland, MI 49464, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Gentex Corporation (Owner Number: 10087496)

Owner / Operator Contact Address

600 North Centennial Street, Zeeland, MI 49464, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

eSight 4 eSight Go OtoSight Middle Ear Scope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOT	Aid, Vision Image Intensification	Ophthalmic	Class 1	886.5910	2024-01-19
QJG	Device System, Imaging, Tympanic Membrane And Middle Ear	Radiology	Class 2	892.1560	2025-04-14

Official Correspondent

Dave Newhouse

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gentex Corporation

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3021892531	ACUCELA DBA KUBOTA VISION	Seattle, WA, US
3013436538	RAY VISION INC.	Lake Forest, CA, US
3003951061	M/S TARUN ENTERPRISES	Prayagraj, Uttar Pradesh, IN
3008309602	ESCHENBACH OPTIK GMBH + CO	Nurnberg Bavaria, DE
3016597890	PHOTONICARE INC	Durham, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000261180. Last updated year: 2026. Please use registration number 1000261180 when referencing this establishment in official correspondence.