Bioseal Inc.

Silicone Tubing - Customer Supplied

Registry build 21.09.26
58manufacturers in China registered for this device type
169catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (19), Guangdong (14), Zhejiang (9). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GCY
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Firstar Healthcare Company Limited (Guangzhou) Guangzhou Guangdong Contract manufacturer 57
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Conod Medical Shuyang Co., Ltd. Shuyang Jiangsu Contract manufacturer 22
Shun SZE Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 22
Primecare Medical (Suzhou) Co., Ltd. Changshu Jiangsu Contract manufacturer 20
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Ningbo Albert Novosino Co., Ltd. Yuyao Zhejiang Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13
Changshu Beyond Medical Device Co., Ltd. Changshu Jiangsu Contract manufacturer 9
Fansheng Technology (Guangdong) Co., Ltd. Zhongshan Guangdong Contract manufacturer 8

Showing 12 of 58. All 58 manufacturers in China registered for Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Record

Regulatory record for Bioseal Inc.
Listed by Bioseal, United States
FDA product code GCY
Device type Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device class Class 1
Regulation 21 CFR 878.4680
Establishment Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-11-22

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 25, case of 50, case of 100, case of 5, case of 10
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Bioseal Inc.
Catalogue number Size Status
19665/20 In distribution
19669/05 In distribution
19620D/20 In distribution
19740/20 In distribution
19758/20 In distribution
19788NS/100 In distribution
19666/20 In distribution
19737NS/50 In distribution
19605C/20 In distribution
19643/20 In distribution
19753/25 In distribution
17611/50 In distribution
19625/50 In distribution
19709/20 In distribution
19647/25 In distribution
19736/25 In distribution
19668/20 In distribution
19621/20 In distribution
19789/20 In distribution
19636/20 In distribution
19725/20 In distribution
19771/20 In distribution
19667/20 In distribution
19684/50 In distribution
19624/50 In distribution
19619/25 In distribution
19752/100 In distribution
19773/20 In distribution
19144/25 In distribution
19680/25 In distribution
19683W/20 In distribution
19734/25 In distribution
19739/20 In distribution
17641/50 In distribution
19695/25 In distribution
19708/20 In distribution
19672/50 In distribution
19679/20 In distribution
19768/20 In distribution
19683S/20 In distribution
19720/20 In distribution
19673/20 In distribution
19778/20 In distribution
19783/20 In distribution
17751/25 In distribution
19724/20 In distribution
19641/20 In distribution
19733/50 In distribution
19670/50 In distribution
19764/20 In distribution
19759/20 In distribution
19784/20 In distribution
19613/25 In distribution
19612/20 In distribution
6151/25 In distribution
19661/20 In distribution
19735/20 In distribution
19615/25 In distribution
19631/20 In distribution
19749/20 In distribution
19721/20 In distribution
19685/20 In distribution
19723/50 In distribution
19763/20 In distribution
19756/20 In distribution
17766/50 In distribution
19651/25 In distribution
19676/20 In distribution
19695/20 In distribution
19640/50 In distribution
19761/100 In distribution
19707/10 In distribution
19732/20 In distribution
19632D/25 In distribution
19671/20 In distribution
17751/50 In distribution
19772/20 In distribution
19729/100 In distribution
19718/20 In distribution
17318/20 In distribution
6150/25 In distribution
19750/20 In distribution
19618/20 In distribution
19717/20 In distribution
19698/50 In distribution
17769/50 In distribution
19700/25 In distribution
19082/24 In distribution
4905/25 In distribution
19765/20 In distribution
19785NS/20 In distribution
19769/20 In distribution
19656/25 In distribution
19686/50 In distribution
17923/20 In distribution
19766/50 In distribution
19652/10 In distribution
19662/20 In distribution
19772/100 In distribution
19780/20 In distribution
19625/25 In distribution
19653/20 In distribution
19627/20 In distribution
19687/25 In distribution
19646/25 In distribution
17762/50 In distribution
19633/20 In distribution
19658/25 In distribution
19642/20 In distribution
19640/20 In distribution
19787/20 In distribution
19748/20 In distribution
19762/20 In distribution
6152/50 In distribution
19674/20 In distribution
19738/20 In distribution
19777/20 In distribution
17751RG/50 In distribution
4916/20 In distribution
19781/20 In distribution
19660/25 In distribution
19713/50 In distribution
19790/20 In distribution
17755/50 In distribution
19760/20 In distribution
19786/20 In distribution
19751/100 In distribution
19767/20 In distribution
19630/25 In distribution
19639/50 In distribution
19711/300 In distribution
19655/20 In distribution
19677/20 In distribution
19616/25 In distribution
19757/20 In distribution
19617/25 In distribution
19726/20 In distribution
19696/20 In distribution
19620/20 In distribution
19682/20 In distribution
19754/25 In distribution
19675/20 In distribution
19722/20 In distribution
17601/50 In distribution
19715/20 In distribution
4917/20 In distribution
19776/25 In distribution
19775/20 In distribution
19730/20 In distribution
19664/25 In distribution
19602S/20 In distribution
19774/20 In distribution
17602/50 In distribution
19645/25 In distribution
17751NS/100 In distribution
19623/20 In distribution
19712/20 In distribution
19782/05 In distribution
19755/25 In distribution
19691/20 In distribution
19770/20 In distribution
17602S/20 In distribution
19690/25 In distribution
4381/20 In distribution
17756/50 In distribution
19652/20 In distribution
4380/25 In distribution
17764/50 In distribution
19705/20 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 50
Closed Suction Sunset Healthcare Solutions, Inc. 49
Closed Wound Suction C.R. Bard, Inc. 37
Barovac® Evacuator Closed Wound Drainage System(SS) Sewoon Medical Co., Ltd. 33
Hemovac® Wound Drainage System Zimmer Orthopaedic Surgical Products 23
Barovac® Evacuator Closed Wound Drainage System(PP) Sewoon Medical Co., Ltd. 22
Deluxe Closed Suction System 72hr Sunset Healthcare Solutions, Inc. 20
Tru-Close Suction Drainage System Uresil, LLC 19
Deluxe Closed Suction System Sunset Healthcare Solutions, Inc. 19
Tracheostomy and Suction Accessory Sunset Healthcare Solutions, Inc. 18
S-Vac® Fluted Channel Drain Aspen Surgical Products, Inc. 17
Aspen® Discrete Drain Aspen Surgical Products, Inc. 16

Showing 12 of 110. All products under Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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