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Device Explorer · FDA GUDID · GMDN 64853

Synthetic wound matrix dressing

A sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native s

US‑registered devices105in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile96%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Beijing Kreate Medical Co., Ltd.3230%
Polymedics Innovations Gmbh1918%
Acera Surgical Inc1514%
Polynovo Biomaterials Pty Limited1211%
Gel4Med, Inc.1010%
Ets Wound Care Llc1010%
Sioxmed, Llc44%
Anika Therapeutics, Inc.33%

Top labelers

CompanyDevicesShare
Beijing Kreate Medical Co., Ltd.3230%
Polymedics Innovations Gmbh1918%
Acera Surgical Inc1514%
Polynovo Biomaterials Pty Limited1211%
Gel4Med, Inc.1010%
Ets Wound Care Llc1010%
Sioxmed, Llc44%
Anika Therapeutics, Inc.33%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SurCura Wound MatrixRedermo Wound MatrixSurCura Antibacterial Wound MatrixRedermax® Antibacterial Wound MatrixRedermax Antibacterial Wound MatrixSupraSDRM®Suprathel® CWSuprathel®Restrata MeshedRestrata(R)Restrata MiniMatrixRestrata Wound MatrixG4Derm PlusRV-X1SuprelloG4Derm Plus Synthetic Wound Matrix

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

FDA product codes

CodeNameDevices
QSZAbsorbable Synthetic Wound Dressing81
FRODressing, Wound, Drug34
KGNWound Dressing With Animal-Derived Material(S)10
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic10

GMDN & GCC registration

  • GMDN code 64853 · non‑implantable
  • Single‑use 100% · sterile 96% · Rx‑only 92% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 17Width (Centimeter) · 17Height (Millimeter) · 12Outer Diameter (Millimeter) · 1

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

How many synthetic wound matrix dressing products are registered in the US?

105 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Synthetic wound matrix dressing", from 8 companies. The largest labeler is Beijing Kreate Medical Co., Ltd. with 30% of records.

Which FDA product codes apply?

QSZ (Absorbable Synthetic Wound Dressing), FRO (Dressing, Wound, Drug), KGN (Wound Dressing With Animal-Derived Material(S)), MGQ (Dressing, Wound And Burn, Hydrogel W/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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