Bioseal Inc.

Gel Wrist Thumb Support Brace

Registry build 21.09.26
101manufacturers in China registered for this device type
31catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (31), Zhejiang (21), Jiangsu (19). 28 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FMP
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23
Conod Medical Shuyang Co., Ltd. Shuyang Jiangsu Contract manufacturer 22
Anji Hengfeng Sanitary Material Co., Ltd. Anji Zhejiang Contract manufacturer 20
Jiangsu Reak Healthy Articles Co., Ltd. Yangzhong Jiangsu Contract manufacturer 18
Shenzhen Zhouyang Medical Care Product Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Hubei Dacheng Medical Technology Co., Ltd. Xianning Hubei Contract manufacturer 12
Dongguan Shihui Living Products Ltd. Dongguan Guangdong Contract manufacturer 11
Dongguan Vincent Rehab Devices Company Limited Dongguan Guangdong Contract manufacturer 11
Premier Guard Zhongshan Limited Zhongshan Guangdong Contract manufacturer 10
Dongguan Suscong Healthcare Co., Ltd. Dongguan Guangdong Contract manufacturer 9

Showing 12 of 101. All 101 manufacturers in China registered for Protector, Skin Pressure

Record

Regulatory record for Bioseal Inc.
Listed by Bioseal, United States
FDA product code FMP
Device type Protector, Skin Pressure
Device class Class 1
Regulation 21 CFR 880.6450
Establishment Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-09-20
Record revised 2024-12-11 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, manufacturing date
Packaging Case of 20, case of 50, case of 25, case of 24, case of 2, case of 28
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Bioseal Inc.
Catalogue number Size Status
17411/20 In distribution
1745/25 In distribution
1744/50 In distribution
1750NS/02 In distribution
17430/25 In distribution
17792/50 In distribution
17146/28 In distribution
19395/05 In distribution
17519/24 In distribution
1744/25 In distribution
17524NS/50 In distribution
1747/20 In distribution
17023/50 In distribution
17410/50 In distribution
1749/20 In distribution
17145/20 In distribution
1741/50 In distribution
1745/50 In distribution
17421NS/20 In distribution
1746/20 In distribution
1742/25 In distribution
17413/20 In distribution
17524/20 In distribution
17590/20 In distribution
17434/24 In distribution
17133/20 In distribution
17524/50 In distribution
17412/20 In distribution
17425/20 In distribution
17424/50 In distribution
1742/10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Action® Action Products, Inc. 485
Primo ASP Global, LLC 147
Allen Hill-ROM, Inc. 141
Blue Diamond David Scott Company. 114
DeRoyal Deroyal Industries, Inc. 85
Primo/ASP Medical ASP Global, LLC 68
Darco® Toe Cap Darco (Europe) GmbH 52
Mölnlycke®Z-Flo™ Fluidized Positioner Mölnlycke Health Care AB 50
TUFFease® Innovative Medical Products, Inc. 43
Darco® PegContour™ Insole Darco (Europe) GmbH 26
SpandaNette Medi-Tech, Inc. 23
Dermacare Ehob, Inc. 23

Showing 12 of 783. All products under Protector, Skin Pressure

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