Kegel

Silicone Scar Sheets: The silicone scar sheets consists of a backing, silcone gel and an anti-stick layer(removed when using).

Registry build 21.09.26
85manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (23), Jiangsu (14), Shanghai (13). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MDA
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Hubei V-Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 46
Shanghai Care Us Medical Product Co., Ltd. Shanghai Shanghai Contract manufacturer 30
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Changzhou Recoo Healthcare Co., Ltd. Changzhou Jiangsu Contract manufacturer 19
Henso Medical (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Huizhou Foryou Medical Devices Co., Ltd. Huizhou Guangdong Contract manufacturer 18
Henan Huibo Medical Co., Ltd. Nanyang Henan Contract manufacturer 17
Zhende Medical Co., Ltd. Shaoxing Zhejiang Contract manufacturer 14
Shanghai Chuangshi Medical Technology (Group) Co., Ltd. Shanghai Shanghai Contract manufacturer 14
Winner Medical (Huanggang) Co., Ltd. Huanggang Hubei Contract manufacturer 9
Smith & Nephew (Suzhou) Limited Suzhou Jiangsu Contract manufacturer 6

Showing 12 of 85. All 85 manufacturers in China registered for Elastomer, Silicone, For Scar Management

Record

Regulatory record for Kegel
Listed by Star Port Inc, United States
FDA product code MDA
Device type Elastomer, Silicone, For Scar Management
Device class Class 1
Regulation 21 CFR 878.4025
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2026-04-25

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Kegel
Catalogue number Size Per pack Status
SC-03 5 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
EPI-Derm Biodermis LLC 77
Scar AID Biodermis LLC 57
NewGel+ Silicone Gel Sheeting Newmedical Technology, Inc. 28
Silagen Silicone Gel Sheeting Newmedical Technology, Inc. 24
Dermasof Biodermis LLC 20
ScarMD AIM Medical Inc 14
Scar Fx Scar Heal 14
Cimeosil® Scar Management, Gel Sheet Implantech Associates, Inc. 13
Therafoam Biodermis LLC 10
Gelzone Wrap Implantech Associates, Inc. 10
NEW Beginnings® Gelshapes® PMT Corp. 9
Invisiderm™ Scar Management, Gel Sheet Implantech Associates, Inc. 8

Showing 12 of 137. All products under Elastomer, Silicone, For Scar Management

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