Consulting Wallah › Device Explorer › Other devices › Skin topical coupling gel
Device Explorer · FDA GUDID · GMDN 15321

Skin topical coupling gel

A medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system,) and the patient, allowing for th

US‑registered devices286in commercial distribution
Companies42labelers on GUDID
Single‑use40%of device records
Sterile7%labelled sterile
Prescription20%Rx‑only share
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Share of device records

Eco-Med Pharmaceutical Inc4215%
National Therapy Products Inc3713%
Next Medical Products, Llc3613%
Pharmaceutical Innovations Inc269%
Hr Pharmaceuticals Inc.124%
Red Medical Supplies Ltd93%
Parker Laboratories Inc93%
Medline Industries, Inc.83%

Top labelers

CompanyDevicesShare
Eco-Med Pharmaceutical Inc4215%
National Therapy Products Inc3713%
Next Medical Products, Llc3613%
Pharmaceutical Innovations Inc269%
Hr Pharmaceuticals Inc.124%
Red Medical Supplies Ltd93%
Parker Laboratories Inc93%
Medline Industries, Inc.83%
Bracco Diagnostics Inc.83%
Prestige Ameritech, Ltd.62%
Drive Devilbiss Healthcare62%
Owens & Minor Distribution, Inc.52%

Company = labeler of record on GUDID. 42 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Swiss DolorClastEndyGelRED Medical SuppliesWALLACH® Summit Doppler™ Ultrasound Gel 250 gramWALLACH® Summit Doppler™ Ultrasound Gel 60 gramsMETRONdBsonx™Nu Skin Conductive GelTendoNova Ocelotsam Single Peel Arthritis Coupling Patchessam(R) Advanced Gel Capture Patchsam coupling patchAquaflexDelphinus Sequr™STERILE AQUASONICHCT

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

FDA product codes

CodeNameDevices
ITXTransducer, Ultrasonic, Diagnostic93
MUIMedia,Coupling,Ultrasound71
IYOSystem, Imaging, Pulsed Echo, Ultrasonic52
MUIMedia, Coupling, Ultrasound37
MUIMedia, coupling, ultrasound24
MUIMedia,coupling,ultrasound21

GMDN & GCC registration

  • GMDN code 15321 · non‑implantable
  • Single‑use 40% · sterile 7% · Rx‑only 20% · OTC 9%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Liter) · 17Weight (Gram) · 12Total Volume (Fluid Ounce) · 10Total Volume (Milliliter) · 9Length (Millimeter) · 3Total Volume (Gallon) · 3

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

How many skin topical coupling gel products are registered in the US?

286 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Skin topical coupling gel", from 42 companies. The largest labeler is Eco-Med Pharmaceutical Inc with 15% of records.

Which FDA product codes apply?

ITX (Transducer, Ultrasonic, Diagnostic), MUI (Media,Coupling,Ultrasound), IYO (System, Imaging, Pulsed Echo, Ultrasonic), MUI (Media, Coupling, Ultrasound)

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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