Gynex

64 catalogue numbers from 1010, listed by Gynex Corporation, United States, under Forceps, Biopsy, Gynecological. 11 manufacturers in China are registered for this product code.

Registry build 21.09.26
11manufacturers in China registered for this device type
64catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HFB
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Guangdong MacroLux Medical Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 9
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Scivita Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 19
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Hangzhou Stellarmed Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 15
Zhuji Pengtian Medical Instrument Co., Ltd. Zhuji Zhejiang Manufacturer 10
Macrolux Medical Technology Co., Ltd. Shenzhen Guangdong Manufacturer 9
Jiangsu Jiyuan Medical Technology Co., Ltd. Taizhou Jiangsu Specification developer 3

Record

Regulatory record for Gynex
Listed by Gynex Corporation, United States
FDA product code HFB
Device type Forceps, Biopsy, Gynecological
Device class Class 1
Regulation 21 CFR 884.4530
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2023-06-28

Specifications

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

Catalogue Numbers

Catalogue numbers for Gynex
Catalogue number Size Status
1010 In distribution
TT007 In distribution
1205 In distribution
1220 In distribution
1200-40 In distribution
1008 In distribution
1025 In distribution
1045 In distribution
1022 In distribution
TB005 In distribution
1230 In distribution
1007 In distribution
1200-15 In distribution
TT036 In distribution
TT030 In distribution
1021 In distribution
1210 In distribution
TT031 In distribution
TAU005 In distribution
TT010 In distribution
TB010 In distribution
1035 In distribution
1200-30 In distribution
1026 In distribution
1200-25 In distribution
TA005 In distribution
1053 In distribution
1235 In distribution
1050 In distribution
1005 In distribution
1033 In distribution
1200-10 In distribution
1012 In distribution
1014 In distribution
1225 In distribution
1200 In distribution
1029 In distribution
1037 In distribution
1075 In distribution
TT011 In distribution
1215 In distribution
1006 In distribution
1200-35 In distribution
TA010 In distribution
1240 In distribution
1070 In distribution
1015 In distribution
TT035 In distribution
1200-05 In distribution
1030 In distribution
1020 In distribution
1027 In distribution
1017 In distribution
1065 In distribution
TT037 In distribution
TT005 In distribution
1200-20 In distribution
TT006 In distribution
1019 In distribution
TT032 In distribution
TAU010 In distribution
1060 In distribution
1039 In distribution
TT012 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Endoch Endoch Inc 160
Marina Medical Marina Medical Instruments, Inc. 142
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 52
Aesculap Aesculap AG 49
Novo Surgical Novo Surgical, Inc. 44
Hayden Medical Hayden Medical Inc 37
Integra® Miltex® Integra LifeSciences Production Corporation 34
BR Surgical, LLC BR Surgical LLC 33
Novo Surgical Inc. Novo Surgical, Inc. 29
Raw Surgical Corporation RAW Surgical Corporation 26
Millennium Avalign Technologies, Inc. 24
Integra® Jarit® Integra LifeSciences Production Corporation 20

Showing 12 of 131. All products under Forceps, Biopsy, Gynecological

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