Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016250458

FEI Number

3016250458

Entity Name

ILLUMIGYN LTD.

City/State/Country

Neve Ilan Central, IL

Establishment Address

Communication Center, Neve Ilan, Neve Ilan Central 9085000, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Illumigyn Ltd. (Owner Number: 10062009)

Owner / Operator Contact Address

Communication Center, Neve Ilan, Neve Ilan, IL-M 9085000, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190187

PMA Number

N/A

All Registered Proprietary Names

Gynescope System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2019-12-11
HEX	Colposcope (And Colpomicroscope)	Obstetrics/Gynecology	Class 2	884.1630	2019-12-11

Official Correspondent

Gusti Averbuch

US Agent Details

Naphtali Deutsch Business: A. Stein - Regulatory Affairs Consulting Email: ahava@asteinrac.com Phone: (888) 4433867

Related Public Records

Same Entity

Illumigyn Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016250458. Last updated year: 2026. Please use registration number 3016250458 when referencing this establishment in official correspondence.