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Device Explorer · FDA GUDID · GMDN 40803

Infrared thermography system

A system using infrared photography or other infrared detection techniques to produce images or graphical representations of the distribution of body surface temperature for the purpose of diagnosing and assessing various conditions and disease states. Also re

US‑registered devices52in commercial distribution
Companies7labelers on GUDID
Single‑use6%of device records
Sterile0%labelled sterile
Prescription15%Rx‑only share
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Share of device records

Meditherm Incorporated4281%
Thermidas Oy48%
Moleculight Inc24%
Neko Health Ab12%
Usa Therm, Inc.12%
Swift Medical Inc12%
Medicore Co., Ltd.12%

Top labelers

CompanyDevicesShare
Meditherm Incorporated4281%
Thermidas Oy48%
Moleculight Inc24%
Neko Health Ab12%
Usa Therm, Inc.12%
Swift Medical Inc12%
Medicore Co., Ltd.12%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Neko HealthThermidasThermPixMolecuLightDX+ Thermal Eco ClipThermal Imaging ModuleRay 1MedithermIRIS-XP

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

FDA product codes

CodeNameDevices
LHQSystem, Telethermographic (Adjunctive Use)50
FXNTape, Camera, Surgical3
FTTCamera, Still, Surgical1
QJFAutofluorescence Imaging Adjunct Tool For Wounds1

GMDN & GCC registration

  • GMDN code 40803 · non‑implantable
  • Single‑use 6% · sterile 0% · Rx‑only 15% · 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

No structured size data on the register.

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

How many infrared thermography system products are registered in the US?

52 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Infrared thermography system", from 7 companies. The largest labeler is Meditherm Incorporated with 81% of records.

Which FDA product codes apply?

LHQ (System, Telethermographic (Adjunctive Use)), FXN (Tape, Camera, Surgical), FTT (Camera, Still, Surgical), QJF (Autofluorescence Imaging Adjunct Tool For Wounds)

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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