Who else makes this device?

Name: Gynius
Brand: Gynius

Obstetrics & Gynecology › DiagnosticColposcope (And Colpomicroscope)

Gynius

The Gynocular is a colposcope intended to provide magnified visualization for the tissues of the vagina, cervix and the external genitalia. It Is used to evaluate these tissues and select…

Registry build 21.09.26

The Gynocular is a colposcope intended to provide magnified visualization for the tissues of the vagina, cervix and the external genitalia. It Is used to evaluate these tissues and select areas for biopsy.

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangxi (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HEX
Manufacturer	City	Province	Registered as	Device types
Shenzhen Goldcare Meditech Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	2
Alltion (Guangxi) Instrument Co., Ltd.	Wuzhou	Guangxi	Manufacturer	8
Xuzhou Kernel Medical Equipment Co Ltd	Xuzhou	Jiangsu	Contract manufacturer	7
Beijing Tech Instrument Co., Ltd.	Chongwen District	Beijing	Manufacturer	1

Record

Regulatory record for Gynius
Listed by	Gynius AB, Sweden
FDA product code	HEX
Device type	Colposcope (And Colpomicroscope)
Device class	Class 2
Regulation	21 CFR 884.1630
Record published	2016-09-22
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	lot or batch number, manufacturing date, serial number
Storage	Storage environment humidity up to 80 % RH; Storage environment temperature -10 to 70 °C; Handling environment temperature 10 to 40 °C

Catalogue Numbers

Catalogue numbers for Gynius
Catalogue number	Size	Status
V1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Leisegang	Coopersurgical, Inc.	17
Microscope Colposcope	Ecleris SRL	16
Bovie	Aspen Surgical Products, Inc.	15
Henry Schein	Henry Schein, Inc.	15
Galileo Colposcope, Direct Access	Gynex Corporation	11
Microstar Colposcope	Ecleris SRL	11
Wallach	Coopersurgical, Inc.	7
Kernel	Xuzhou Kernel Medical Equipment Co Ltd	6
McKesson	Mckesson Medical-Surgical Inc.	5
Unico ColpoMaster I	United Products & Instruments, Inc.	4
Gynex	Gynex Corporation	4
medgyn video colposcope	Medgyn Products, Inc.	3

Showing 12 of 42. All products under Colposcope (And Colpomicroscope)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K132423	2014-04-08

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.