Rystora Silicone Scar Gel
Catalogue number SGA01501, listed by Fortune Medical Instrument Corp., Taiwan, under Silicone Hydrogel For Scar Management. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
1catalogue number
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 | Fortune Medical Instrument Corp., Taiwan |
|---|---|
| FDA product code | PFP |
| Device type | Silicone Hydrogel For Scar Management |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4025 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-12-30 |
| Record revised | 2024-02-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SGA01501 | 24 | 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 |
| Silicone Hydrogel For Scar Management | Henan Maidingkang Medical Technology Co., Ltd. | 2 |
| 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.