Consulting Wallah › Device Explorer › Wound care & sutures › Synthetic polymer semi-permeable film dressing, ad
Device Explorer · FDA GUDID · GMDN 58301

Synthetic polymer semi-permeable film dressing, adhesive

A transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of syntheti

US‑registered devices454in commercial distribution
Companies44labelers on GUDID
Single‑use100%of device records
Sterile86%labelled sterile
Prescription20%Rx‑only share
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Share of device records

3M Company8419%
Bedal5312%
3M Deutschland Gmbh4811%
Cardinal Health 200, Llc276%
Sion Brands Llc225%
Deroyal Industries, Inc.194%
Paul Hartmann Ag184%
Lohmann & Rauscher International Gmbh & Co Kg143%

Top labelers

CompanyDevicesShare
3M Company8419%
Bedal5312%
3M Deutschland Gmbh4811%
Cardinal Health 200, Llc276%
Sion Brands Llc225%
Deroyal Industries, Inc.194%
Paul Hartmann Ag184%
Lohmann & Rauscher International Gmbh & Co Kg143%
Dynarex Corporation143%
Healqu Llc123%
Shanghai Iso Medical Products Co., Ltd.102%
Covalon Technologies Ltd102%

Company = labeler of record on GUDID. 44 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FlexmarMepore® FilmNAKONLIDAOurmed Transparent DressingBGEcare Sterile Non-woven Island DressingGentellTransparent Adhesive Film DressingEyePro™ Eyelid CoversSequaFilm PU Film DressingFlexGRIPBedalOPSITE™ FLEXIGRIDOPSITE FLEXIGRID USA 10X12CM CARTON OF 10OPSITE FLEXIGRID USA 6X7CM-CARTON OF 100FloSure

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

FDA product codes

CodeNameDevices
NADDressing, wound, occlusive116
KMKDevice, Intravascular Catheter Securement94
NADDressing, Wound, Occlusive84
KMKDEVICE, INTRAVASCULAR CATHETER SECUREMENT61
KGXTape And Bandage, Adhesive34
KGXTape and bandage, adhesive31

GMDN & GCC registration

  • GMDN code 58301 · non‑implantable
  • Single‑use 100% · sterile 86% · Rx‑only 20% · OTC 31%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 42Length (Inch) · 41Length (Centimeter) · 19Width (Centimeter) · 19Length (Millimeter) · 14Width (Millimeter) · 14

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

How many synthetic polymer semi-permeable film dressing, adhesive products are registered in the US?

454 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Synthetic polymer semi-permeable film dressing, adhesive", from 44 companies. The largest labeler is 3M Company with 19% of records.

Which FDA product codes apply?

NAD (Dressing, wound, occlusive), KMK (Device, Intravascular Catheter Securement), NAD (Dressing, Wound, Occlusive), KMK (DEVICE, INTRAVASCULAR CATHETER SECUREMENT)

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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