Device Explorer · FDA GUDID · GMDN 15652

Loupe

A convex lens with an built-in, electrical light source used for magnifying vision and concentrating the light upon an object or objects being viewed. It can be used for a variety of purposes, e.g., the examination of an object for laboratory work, diagnosis,

US‑registered devices69in commercial distribution
Companies6labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Sontec Instruments, Inc.2841%
Jedmed Instrument Company2841%
Practicon, Inc.69%
Karl Storz Gmbh & Co. Kg46%
Leica Microsystems (Schweiz) Ag23%
Dentlight Inc.11%

Top labelers

CompanyDevicesShare
Sontec Instruments, Inc.2841%
Jedmed Instrument Company2841%
Practicon, Inc.69%
Karl Storz Gmbh & Co. Kg46%
Leica Microsystems (Schweiz) Ag23%
Dentlight Inc.11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

n.a.iZoom LoupesTTL Easy Size 3.0X Loupes BlackTTL Easy Size 2.5X Loupes BlackTTL Easy Size 3.0X Loupes SilverTTL Easy Size 2.5X Loupes SilverTTL Easy Size 3.0X Loupes RedTTL Easy Size 2.5X Loupes RedMINI 3000 COMBINATION SETLOUPE LIGHT 2LOUPE CARRIER SCREWLOUPE CARRIERI-VIEWNOSE PAD SETI-VIEW LOUPE CARRIEROMEGA 500 LED MODULE

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

FDA product codes

CodeNameDevices
FSPLOUPE, DIAGNOSTIC/SURGICAL50
HPPHeadlamp, Operating, Battery-Operated28
FSPLoupe, Diagnostic/Surgical7
ERAOTOSCOPE2
HJILens, Fundus, Hruby, Diagnostic2
HRMMICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC2

GMDN & GCC registration

  • GMDN code 15652 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 49% · 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 (Millimeter) · 1

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

No closely related category with 50+ devices.

How many loupe products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Loupe", from 6 companies. The largest labeler is Sontec Instruments, Inc. with 41% of records.

Which FDA product codes apply?

FSP (LOUPE, DIAGNOSTIC/SURGICAL), HPP (Headlamp, Operating, Battery-Operated), FSP (Loupe, Diagnostic/Surgical), ERA (OTOSCOPE)

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.

How do I get quotes?

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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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