A covering made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin
| Company | Devices | Share |
|---|---|---|
| Biodermis Llc | 188 | 42% |
| Newmedical Technology, Inc. | 52 | 12% |
| Bio Med Sciences, Inc. | 47 | 11% |
| Implantech Associates, Inc. | 33 | 7% |
| Henan Maidingkang Medical Technology Co., Ltd. | 28 | 6% |
| Scar Heal | 14 | 3% |
| Hangzhou R&L Medical Device Co., Ltd | 8 | 2% |
| Fortune Medical Instrument Corp. | 8 | 2% |
| Alliance Pharma Inc. | 8 | 2% |
| Skingen Uk Ltd | 7 | 2% |
| Henan Huibo Medical Co.,Ltd. | 5 | 1% |
| Hanson Medical, Inc. | 5 | 1% |
Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | 360 |
| MDA | Elastomer, silicone, for scar management | 47 |
| PFP | Silicone Hydrogel For Scar Management | 39 |
| KGX | Tape And Bandage, Adhesive | 1 |
Use these as the dimensions to specify in a tender line.
444 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Scar-management dressing, reusable", from 31 companies. The largest labeler is Biodermis Llc with 42% of records.
MDA (Elastomer, Silicone, For Scar Management), MDA (Elastomer, silicone, for scar management), PFP (Silicone Hydrogel For Scar Management), KGX (Tape And Bandage, Adhesive)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.