Who else makes this device?

Name: Unico ColpoMaster I
Brand: Unico ColpoMaster I

Obstetrics & Gynecology › DiagnosticColposcope (And Colpomicroscope)

Unico ColpoMaster I

CS-103T-LED Colposcope Articulating Arm, Trinocular Zoom Head, Three Legged Base. LED Illumination

Registry build 21.09.26

4manufacturers in China registered for this device type

4catalogue numbers in this listing

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 Unico ColpoMaster I
Listed by	United Products & Instruments, Inc., United States
FDA product code	HEX
Device type	Colposcope (And Colpomicroscope)
Device class	Class 2
Regulation	21 CFR 884.1630
Establishment	Repacker / relabeller
510(k)	K073053
Record published	2016-08-23
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Unico ColpoMaster I
Catalogue number	Size	Status
CS-105T-LED		In distribution
CS-105LED		In distribution
CS-103LED		In distribution
CS-103T-LED		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
Gynex	Gynex Corporation	4
medgyn video colposcope	Medgyn Products, Inc.	3
MedGyn Gynescope	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
K073053	2007-11-15

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.