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Device Explorer · FDA GUDID · GMDN 16800

Vision testing/training chart

An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. T

US‑registered devices59in commercial distribution
Companies18labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription19%Rx‑only share
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Share of device records

Oculus Optikgeräte Gesellschaft Mit Beschränkter Haftung1220%
Ama Optics, Inc.1119%
Reichert, Inc.58%
Haag-Streit Uk Limited47%
Huvitz Co., Ltd.47%
Nidek Co.,Ltd.35%
Optego Vision Usa Inc.35%
Bernell35%

Top labelers

CompanyDevicesShare
Oculus Optikgeräte Gesellschaft Mit Beschränkter Haftung1220%
Ama Optics, Inc.1119%
Reichert, Inc.58%
Haag-Streit Uk Limited47%
Huvitz Co., Ltd.47%
Nidek Co.,Ltd.35%
Optego Vision Usa Inc.35%
Bernell35%
Chongqing Sunkingdom Medical Instrument Co.,Ltd23%
Ningbo Ming Sing Optical R & D Co., Ltd.23%
Gobiquity, Inc.23%
View-M Technology Co., Ltd.23%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sunkingdom RetinometerYEASNLCD Chart monitorLCD CHART MONITORHaag-Streit UKClement Clarke OphthalmicTabletop Refraction SystemSYSTEM CHARTSPACE SAVING CHARTC-Test DistanceNear vision test 2Visual acuity chart for H-TestC-Test, Vision acuity testSet eye chartsEye chart, pictures for children according to LöEye chart, E-hook

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

FDA product codes

CodeNameDevices
HOXChart, Visual Acuity61
MMFPhotorefractor8
HKORefractometer, Ophthalmic8
HLCInstrument, Measuring, Stereopsis3
HJNTransilluminator, Battery-Powered3
HKNRefractor, Manual, Non-Powered, Including Phoropter2

GMDN & GCC registration

  • GMDN code 16800 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 19% · OTC 7%
  • 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 vision testing/training chart products are registered in the US?

59 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vision testing/training chart", from 18 companies. The largest labeler is Oculus Optikgeräte Gesellschaft Mit Beschränkter Haftung with 20% of records.

Which FDA product codes apply?

HOX (Chart, Visual Acuity), MMF (Photorefractor), HKO (Refractometer, Ophthalmic), HLC (Instrument, Measuring, Stereopsis)

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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