Consulting Wallah › Device Explorer › Wound care & sutures › Wound hydrogel dressing, non-antimicrobial
Device Explorer · FDA GUDID · GMDN 47764

Wound hydrogel dressing, non-antimicrobial

A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb

US‑registered devices291in commercial distribution
Companies65labelers on GUDID
Single‑use77%of device records
Sterile58%labelled sterile
Prescription30%Rx‑only share
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Share of device records

Sonoma Pharmaceuticals, Inc.3612%
Medical Devices, Inc.228%
Bsn Medical Gmbh217%
Medline Industries, Inc.207%
Safe N' Simple Llc155%
Medi-Tech International Corporation124%
3M Deutschland Gmbh93%
Lavior Pharma Inc.83%

Top labelers

CompanyDevicesShare
Sonoma Pharmaceuticals, Inc.3612%
Medical Devices, Inc.228%
Bsn Medical Gmbh217%
Medline Industries, Inc.207%
Safe N' Simple Llc155%
Medi-Tech International Corporation124%
3M Deutschland Gmbh93%
Lavior Pharma Inc.83%
Crawford Healthcare Limited62%
Sion Brands Llc62%
North American Rescue, Llc62%
Derma Sciences Canada Inc62%

Company = labeler of record on GUDID. 65 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sion Biotext Medical Ltd.MEDLOTNAAUVONPreviClear Border Sacrum Transparent Gel Dressinkegel Hydrogel DressingHyegiirPurilonOptiheal Hydration Multi Purpose DressingKerraLite Cool BorderKerraLite CoolH&HSurprasorb3M™ Nu-Gel™3M™ Kerralite Cool™Cutimed®

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

FDA product codes

CodeNameDevices
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic134
NADDressing, Wound, Occlusive53
NAEDressing, wound, hydrogel without drug and/or biologic49
FRODressing, Wound, Drug37
FRODressing, wound, drug19
MGQDressing, wound and burn, hydrogel w/drug and/or biologic17

GMDN & GCC registration

  • GMDN code 47764 · non‑implantable
  • Single‑use 77% · sterile 58% · Rx‑only 30% · 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

Weight (Gram) · 43Length (Inch) · 24Length (Centimeter) · 22Width (Centimeter) · 22Height (Inch) · 18Width (Inch) · 8

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

How many wound hydrogel dressing, non-antimicrobial products are registered in the US?

291 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Wound hydrogel dressing, non-antimicrobial", from 65 companies. The largest labeler is Sonoma Pharmaceuticals, Inc. with 12% of records.

Which FDA product codes apply?

NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic), NAD (Dressing, Wound, Occlusive), NAE (Dressing, wound, hydrogel without drug and/or biologic), FRO (Dressing, Wound, Drug)

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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