Consulting Wallah › Device Explorer › Other devices › Dermatoscope, optical
Device Explorer · FDA GUDID · GMDN 18021

Dermatoscope, optical

An electrically-powered, hand-held instrument intended to be used for the direct microscopic examination of the external skin layers. The device has a built-in light source and magnification system that provides the user with the visualization of the structure

US‑registered devices324in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile1%labelled sterile
Prescription4%Rx‑only share
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Share of device records

Dermlite Llc17755%
American Diagnostic Corp9730%
Heine Optotechnik Gmbh & Co. Kg3110%
Metaoptima Technology Inc113%
Welch Allyn, Inc.41%
Deepx Health, Llc21%
Timesco Healthcare Limited10%
Rudolf Riester Gmbh10%

Top labelers

CompanyDevicesShare
Dermlite Llc17755%
American Diagnostic Corp9730%
Heine Optotechnik Gmbh & Co. Kg3110%
Metaoptima Technology Inc113%
Welch Allyn, Inc.41%
Deepx Health, Llc21%
Timesco Healthcare Limited10%
Rudolf Riester Gmbh10%

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

Brand names on the register (sample)

Orion DiagnosticsDELTA X CPGDELTA X CPPDELTA XDELTAoneDELTA 30 UVDELTA 30 PROHEINE diSTANCEiC1DELTA 30DELTAone CONTACT PLATECONTACT PLATE DELTA 30CONTACT PLATE iC1DELTA 20TCONTACT PLATE DELTA 20TMINI3000 LED

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

FDA product codes

CodeNameDevices
KYTLight, Examination, Medical, Battery Powered218
IBJLight, Microscope98
ERAOtoscope97
HLJOphthalmoscope, Battery-Powered97
DXQBlood Pressure Cuff23
DXNSystem, Measurement, Blood-Pressure, Non-Invasive5

GMDN & GCC registration

  • GMDN code 18021 · non‑implantable
  • Single‑use 0% · sterile 1% · Rx‑only 4% · OTC 86%
  • 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 dermatoscope, optical products are registered in the US?

324 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dermatoscope, optical", from 8 companies. The largest labeler is Dermlite Llc with 55% of records.

Which FDA product codes apply?

KYT (Light, Examination, Medical, Battery Powered), IBJ (Light, Microscope), ERA (Otoscope), HLJ (Ophthalmoscope, Battery-Powered)

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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