ManipulatOR

Uterine Manipulator

Registry build 21.09.26
5manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Zhejiang (2), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LKF
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Tonglu Qianyan Medtech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Zhejiang Huanyi Sterilization Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 25
Beijing Hangtian Kadi Technology R&D Institute Beijing Beijing Manufacturer 5

Record

Regulatory record for ManipulatOR
Listed by Surgi Supplies International PTY. Ltd.
FDA product code LKF
Device type Cannula, Manipulator/Injector, Uterine
Device class Class 2
Regulation 21 CFR 884.4530
Record published 2016-11-09
Record revised 2023-04-04 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Shipper box of 6, outer box of 5

Catalogue Numbers

Catalogue numbers for ManipulatOR
Catalogue number Size Status
UM-TV In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Elmed Elmed, Inc. 39
Cannula, Manipulator/Injector, Uterine C R I 31
Marina Medical Marina Medical Instruments, Inc. 29
HSG Catheter Titus Medical LLC 26
HNM Women Care HNM Stainless, LLC. 20
Bioteque Bioteque Taiwan Ltd. 16
Viky Endocontrol 15
Cannula, Manipulator/Injector, Uterine Panpac Medical Corporation 14
Uterine ElevatOR Pro THE O R Company PTY Ltd 12
Valtchev Uterine Mobilizer Conkin Surgical Instruments Ltd. 10
Novo Surgical Novo Surgical, Inc. 9
McCarus-Volker Fornisee® System LSI Solutions Inc. 9

Showing 12 of 111. All products under Cannula, Manipulator/Injector, Uterine

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer