Bioseal Inc.

Heart Tourniquet 8 Fr - 3/4"

Registry build 21.09.26
124manufacturers in China registered for this device type
36catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (47), Jiangsu (26), Guangdong (16). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GAX
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Zhejiang Hongyu Medical Commodity Co., Ltd. Yiwu Zhejiang Contract manufacturer 36
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Anji Hengfeng Sanitary Material Co., Ltd. Anji Zhejiang Contract manufacturer 20
Changzhou Recoo Healthcare Co., Ltd. Changzhou Jiangsu Contract manufacturer 19
Xiantao Rayxin Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 18
Hangzhou Aosi Healthcare Co., Ltd. Hangzhou Zhejiang Contract manufacturer 18
Nantong City Yojo Medical Products Co., Ltd. Haimen Jiangsu Contract manufacturer 14
Jiangsu Senolo Medical Technology Co., Ltd. Yancheng Jiangsu Contract manufacturer 12
Vistar Medical Supplies Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Wenzhou Dongfang Medical Instruments Co., Ltd. Wenzhou Zhejiang Contract manufacturer 10
Elite Medtek(Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 9

Showing 12 of 124. All 124 manufacturers in China registered for Tourniquet, Nonpneumatic

Record

Regulatory record for Bioseal Inc.
Listed by Bioseal, United States
FDA product code GAX
Device type Tourniquet, Nonpneumatic
Device class Class 1
Regulation 21 CFR 878.5900
Establishment Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-01-24

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 24, case of 10, case of 20, case of 25, case of 125, case of 100
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Bioseal Inc.
Catalogue number Size Status
4902/20 In distribution
4910/25 In distribution
4921/10 In distribution
4913/20 In distribution
19011/10 In distribution
4918/25 In distribution
19050/24 In distribution
4907/20 In distribution
19014/10 In distribution
19017/20 In distribution
4920/10 In distribution
4299/24 In distribution
4918RG/125 In distribution
4923/10 In distribution
19090/24 In distribution
4922/10 In distribution
19018/24 In distribution
4903/24 In distribution
4918/100 In distribution
4908/24 In distribution
4905/24 In distribution
4904/10 In distribution
4912/20 In distribution
4909/20 In distribution
19091/24 In distribution
4915/20 In distribution
4908/10 In distribution
19022/20 In distribution
4905/10 In distribution
19020/25 In distribution
19088/24 In distribution
19017/24 In distribution
4906/25 In distribution
4914/20 In distribution
19040/24 In distribution
4924/10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rhino Rescue Wuxi Emsrun Technology Co., Ltd. 55
FCP Bandage First Care Products Ltd. 39
NAR North American Rescue, LLC. 39
Cardinal Health Cardinal Health 200, LLC 29
DeRoyal Deroyal Industries, Inc. 28
Trinity Sterile, Inc. Trinity Sterile, Inc. 25
ASP Medical ASP Global, LLC 20
MedSource Tourniquet Medsource International, LLC 17
Marketlab Marketlab Incorporated 16
Medical Action Industries Medical Action Industries, Inc. 16
Novaplus ASP Global, LLC 15
MediChoice Owens & Minor Distribution, Inc. 14

Showing 12 of 171. All products under Tourniquet, Nonpneumatic

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