Ultrafix Micromite

Ultrafix Micromite Drill Guide

Registry build 21.09.26
110manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (31), Jiangsu (27), Guangdong (20). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MDM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Dongguan Hong De Medical Plastic Products Co., Ltd. Dongguan Guangdong Contract manufacturer 32
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Suzhou Jiangsu Contract manufacturer 19

Showing 12 of 110. All 110 manufacturers in China registered for Instrument, Manual, Surgical, General Use

Record

Regulatory record for Ultrafix Micromite
Listed by ConMed Corporation, United States
FDA product code MDM
Device type Instrument, Manual, Surgical, General Use
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-09-24
Record revised 2024-07-24 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Ultrafix Micromite
Catalogue number Size Status
10298 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Arthrex® Arthrex, Inc. 1,686
TSI Tedan Surgical Innovations, L.L.C. 1,181
Medfix Medfix International, LLC 514
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 446
Fentex Fentex medical GmbH 407
Millennium Avalign Technologies, Inc. 337
Synergetics Synergetics USA, Inc. 312
American Medicals American Medicals 298
gSource Gsource, LLC. 291
Life Instruments Life Instrument Corp. 274
Ambler Surgical Ambler Surgical, LLC 272
Instrument, Manual, Surgical, General Use Karl Storz GmbH & Co. KG 261

Showing 12 of 1,364. All products under Instrument, Manual, Surgical, General Use

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