Defendo

Defendo for Fuji 700, 4-piece Single Use Valve Kit with Air Water, Suction, Biopsy Valve, Cleaning Adapter

Registry build 21.09.26
21manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Zhejiang (7), Shanghai (5). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ODC
Manufacturer City Province Registered as Device types
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Smartdata Suzhou Co., Ltd. Suzhou Jiangsu Contract manufacturer 11
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Rozer Sterilization Technology Shuyang Company Limited Shuyang Jiangsu Contract manufacturer 33
Goals Sterilization Co., Ltd. Jiaxing Zhejiang Contract manufacturer 26
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Wuxi Goals Medical Technology Co., Ltd. Yixing Jiangsu Contract manufacturer 24
Jiana Sterilization Technology (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 23
Alton Shanghai Medical Instruments Co Ltd Shanghai Shanghai Complaint-file establishment 20

Showing 12 of 21. All 21 manufacturers in China registered for Endoscope Channel Accessory

Record

Regulatory record for Defendo
Listed by Medivators Inc, United States
FDA product code ODC
Device type Endoscope Channel Accessory
Device class Class 2
Regulation 21 CFR 876.1500
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k) K232329
Record published 2024-01-18
Record revised 2024-07-25 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 50

Catalogue Numbers

Catalogue numbers for Defendo
Catalogue number Size Status
Defendo Fujifilm 700 Series In distribution
Defendo Fujifilm 700 Series In distribution
Defendo Fujifilm 700 Series In distribution
4008055 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
CeroFrict SML MED-Tech Solutions Limited 60
Disposable Endoscopy Adapter Sets Yangzhou Fartley Medical Instrument Technology Co., Ltd. 14
andorate® Biopsy Valve GA Health Company Limited 8
andorate® 4-piece Valve Kit GA Health Company Limited 8
Cook Cook Incorporated 7
Water Jet Adapter Yangzhou Fartley Medical Instrument Technology Co., Ltd. 7
andorate® 3-piece Valve Kit GA Health Company Limited 7
Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit GA Health Company Limited 7
Defendo Single Use Valve Kit Medivators Inc 6
Disposable Endoscope Valves Kit Shanghai SeeGen Photoelectric Technology Co., Ltd. (YinDu Road Factory) 6
Andorate Smartdata Suzhou Co., Ltd. 6
BullDog® Diversatek Healthcare Inc 6

Showing 12 of 89. All products under Endoscope Channel Accessory

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