Silicone Hydrogel for Scar Management
Scar Sticker (Non-Sterile)
22manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Zhejiang (4), Henan (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| Nanjing 3H Medical Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 25 |
| Taizhou Chenguang Import AND Export Trading Co., Ltd. | Taizhou | Jiangsu | Exporter | 25 |
| Jiangsu Qiantai Medical Instrument Co., Ltd. | Tai Zhou | Jiangsu | Contract manufacturer | 16 |
| Wuhan Huawei Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 16 |
Showing 12 of 22. All 22 manufacturers in China registered for Silicone Hydrogel For Scar Management
Record
| Listed by | Henan Maidingkang Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | PFP |
| Device type | Silicone Hydrogel For Scar Management |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4025 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-06-03 |
| Record revised | 2024-02-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Sterile | In distribution | |
| Non-Sterile | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medlot | Henan Maidingkang Medical Technology Co., Ltd. | 25 |
| R&L Medical | Hangzhou R&L Medical Device Co., Ltd. | 6 |
| LotFancy | Henan Maidingkang Medical Technology Co., Ltd. | 3 |
| Huibo Medical | Henan Huibo Medical Co., Ltd. | 2 |
| Celacyn Scar Management Gel | Sonoma Pharmaceuticals, Inc. | 2 |
| Rystora Silicone Scar Gel | Fortune Medical Instrument Corp. | 1 |
| Advanced Scar & Wound Hydrogel | Sonoma Pharmaceuticals, Inc. | 1 |
| Sensifine | Hangzhou R&L Medical Device Co., Ltd. | 1 |
| Aquanil Recovery Gel | Sonoma Pharmaceuticals, Inc. | 1 |
| Regenacyn Plus Scar Management Hydrogel | Sonoma Pharmaceuticals, Inc. | 1 |
| Regenacyn Advanced Scar Gel | Sonoma Pharmaceuticals, Inc. | 1 |
| Kegel | Star Port Inc | 1 |
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.