AquaGuard

AG-SB, Sample KIT

Registry build 21.09.26
31manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

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

Chinese manufacturers registered for FDA product code KIA
Manufacturer City Province Registered as Device types
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Shanghai Huayue Packaging Products Co., Ltd. Fengxian District Shanghai Contract manufacturer 18
Changzhou DSB Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Xiantao Daoqi Plastic Co., Ltd. Xiantao Hubei Contract manufacturer 16
Haining Yikang Textile Co., Ltd. Haining Zhejiang Contract manufacturer 5
Chengdu Cryo-Push Medical Technology Co., Ltd. Chengdu Sichuan Contract manufacturer 4
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75

Showing 12 of 31. All 31 manufacturers in China registered for Cover, Cast

Record

Regulatory record for AquaGuard
Listed by Tidi Products, LLC, United States
FDA product code KIA
Device type Cover, Cast
Device class Class 1
Regulation 21 CFR 880.6185
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2025-09-23

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for AquaGuard
Catalogue number Size Status
50000-SMP In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Seal-Tight Brownmed 42
easycare Synchronis Medical LLC 18
Vive Vive Health LLC 10
Cover, Cast Ningbo Huirui Technology Co., Ltd. 8
Bios Living Thermor Ltd. 6
Walgreens Walgreen Co. 5
Drive Drive DeVilbiss Healthcare 2
Drivemedical Drive DeVilbiss Healthcare 2
Medi Grade Chengdu Cryo-Push Medical Technology Co., Ltd. 1

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