Sof-Rol®

SOF-ROL Sterile 7.5CM X 3.6MTR 20

Registry build 21.09.26
81manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (26), Jiangsu (19), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITG
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Anji Hengfeng Sanitary Material Co., Ltd. Anji Zhejiang Contract manufacturer 20
Derma Sciences Nantong Incorporation Development Jiangsu Contract manufacturer 19
Xiantao Rayxin Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 18
Jianerkang Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 18
Kingstar Medical (Xianning) Co., Ltd. Xianning Hubei Contract manufacturer 17
Suzhou Avon Textile Co., Ltd. Suzhou Jiangsu Contract manufacturer 12
Anhui Ivymed Medical Products Co., Ltd. Xuancheng Anhui Contract manufacturer 10
Suzhou Dukangning Medical Products Co., Ltd. Suzhou Jiangsu Contract manufacturer 9

Showing 12 of 81. All 81 manufacturers in China registered for Bandage, Cast

Record

Regulatory record for Sof-Rol®
Listed by BSN Medical, Inc., United States
FDA product code ITG
Device type Bandage, Cast
Device class Class 1
Regulation 21 CFR 890.3025
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-09-27
Record revised 2022-12-06 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Over the counter Yes
Label carries lot or batch number, expiry date
Sizes Width 5 to 15 cm; length 360 cm

Catalogue Numbers

Catalogue numbers for Sof-Rol®
Catalogue number Size Per pack Status
72345-12 Width 10 cm 20 In distribution
72345-11 Length 360 cm 20 In distribution
72345-10 Length 360 cm 20 In distribution
72345-13 Width 15 cm 20 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
3M™ Scotchcast™ Solventum US LLC 58
Bandage, Cast Tetra Medical Supply Corp. 55
Tex-Care Medical Flynt Amtex, Inc. 45
DeRoyal Deroyal Industries, Inc. 35
McKesson Mckesson Medical-Surgical Inc. 34
PremierPro Prestige Ameritech 31
Emsrun Wuxi Emsrun Technology Co., Ltd. 25
TCC-EZ® Acell, Inc. 24
Woodcast Dassiet Oy 15
Curity Cardinal Health 14
Cardinal Health Cardinal Health 200, LLC 13
Senolo Jiangsu Senolo Medical Technology Co., Ltd. 13

Showing 12 of 66. All products under Bandage, Cast

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