Consulting Wallah › Device Explorer › Other devices › Electroretinograph
Device Explorer · FDA GUDID · GMDN 11482

Electroretinograph

An ophthalmic device used to record the changes in electric potential on or near the surface of the cornea to a reference distal point on the body, following stimulation of the retina by light, i.e., flashes of white light. The electroretinograph (ERG) recorde

US‑registered devices152in commercial distribution
Companies4labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Diagnosys Llc13689%
Roland Consult Stasche & Finger Gmbh96%
Lkc Technologies, Inc.53%
Metrovision21%

Top labelers

CompanyDevicesShare
Diagnosys Llc13689%
Roland Consult Stasche & Finger Gmbh96%
Lkc Technologies, Inc.53%
Metrovision21%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Vision Monitor - MonPackONEVision Monitor - MonCvONERETI-port/scan 21 delta plusRETI-port/scan 21 gamma plus²RETI-port/scan 21 gamma plusRETI-port/scan 21 gammaRETI-port/scan 21 beta plusRETI-port/scan 21 betaRETI-port/scan 21 alpha plusRETI-port/scan 21 alphaRETI-port/scan 21 basicUTASRETeval™ColorBurst Handheld StimulatorLCD Benchtop Assembly w/ Monitor & Fixation CameColorFlash Handheld Stimulator

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

FDA product codes

CodeNameDevices
GWEStimulator, Photic, Evoked Response186
HLGPupillometer, Ac-Powered7
GXYElectrode, Cutaneous3
HLTPreamplifier, Ac-Powered, Ophthalmic2
OUMAdaptometer (Biophotometer), Software-Based Data Acquisition2
HOXChart, Visual Acuity1

GMDN & GCC registration

  • GMDN code 11482 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 3% · 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.

No closely related category with 50+ devices.

How many electroretinograph products are registered in the US?

152 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electroretinograph", from 4 companies. The largest labeler is Diagnosys Llc with 89% of records.

Which FDA product codes apply?

GWE (Stimulator, Photic, Evoked Response), HLG (Pupillometer, Ac-Powered), GXY (Electrode, Cutaneous), HLT (Preamplifier, Ac-Powered, Ophthalmic)

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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