Consulting Wallah › Device Explorer › Wound care & sutures › Scar-management dressing, single-use
Device Explorer · FDA GUDID · GMDN 47771

Scar-management dressing, single-use

A covering/substance 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 a flexible or elastic sheet/f

US‑registered devices75in commercial distribution
Companies16labelers on GUDID
Single‑use64%of device records
Sterile21%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Aim Medical Inc.1317%
Silipos Holding Llc1216%
Tronjen Medical Technology Inc.912%
Mölnlycke Health Care Ab79%
Newmedical Technology, Inc.79%
Alliance Pharma Inc.79%
Scar Heal68%
Shandong Zhushi Pharmaceutical Group Co., Ltd. First Office23%

Top labelers

CompanyDevicesShare
Aim Medical Inc.1317%
Silipos Holding Llc1216%
Tronjen Medical Technology Inc.912%
Mölnlycke Health Care Ab79%
Newmedical Technology, Inc.79%
Alliance Pharma Inc.79%
Scar Heal68%
Shandong Zhushi Pharmaceutical Group Co., Ltd. First Office23%
Smith & Nephew Medical Limited23%
Hra Pharma America, Inc.23%
Vivera Pharmaceuticals, Inc.23%
Benq Materials Corp.23%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mepiform®NALorskiYoveCareCICA CAREH&HScarMDNewGel+E Advanced Silicone Gel for ScarsSilagen Silicone Gel for Scars + SPF30 UV ProtecSilagen 100% Pure Silicone GelNewGel+UV Silicone Gel for Scars + SPF30Mederma Medical Grade Silicone Scar Sheet Large Mederma Medical Grade Silicone Scar Sheet Small ScarSilRejuvaSilScar Esthetique

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MDAElastomer, Silicone, For Scar Management62
NADDressing, Wound, Occlusive17
MDAElastomer, silicone, for scar management9
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic6
PFPSilicone Hydrogel For Scar Management1
FMPProtector, Skin Pressure1

GMDN & GCC registration

  • GMDN code 47771 · non‑implantable
  • Single‑use 64% · sterile 21% · Rx‑only 3% · OTC 47%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Centimeter) · 17Length (Centimeter) · 16Total Volume (Milliliter) · 6Weight (Gram) · 2Length (Millimeter) · 1Width (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many scar-management dressing, single-use products are registered in the US?

75 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Scar-management dressing, single-use", from 16 companies. The largest labeler is Aim Medical Inc. with 17% of records.

Which FDA product codes apply?

MDA (Elastomer, Silicone, For Scar Management), NAD (Dressing, Wound, Occlusive), MDA (Elastomer, silicone, for scar management), NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic)

Is this the same as UAE/GCC registration?

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.

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