Consulting Wallah › Device Explorer › Ophthalmic › Automated ophthalmic refractometer
Device Explorer · FDA GUDID · GMDN 36386

Automated ophthalmic refractometer

An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient

US‑registered devices114in commercial distribution
Companies25labelers on GUDID
Single‑use0%of device records
Sterile2%labelled sterile
Prescription54%Rx‑only share
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Share of device records

Topcon Corporation1412%
Right Mfg. Co., Ltd.1311%
Nidek Co.,Ltd.1110%
Luneau Technology Operations87%
Alcon Laboratories, Inc.87%
Ningbo Ming Sing Optical R & D Co., Ltd.76%
Johnson & Johnson Surgical Vision, Inc.65%
Tomey Corporation.65%

Top labelers

CompanyDevicesShare
Topcon Corporation1412%
Right Mfg. Co., Ltd.1311%
Nidek Co.,Ltd.1110%
Luneau Technology Operations87%
Alcon Laboratories, Inc.87%
Ningbo Ming Sing Optical R & D Co., Ltd.76%
Johnson & Johnson Surgical Vision, Inc.65%
Tomey Corporation.65%
Shenzhen Certainn Technology Co., Ltd.54%
Rexxam Co., Ltd.54%
Carl Zeiss Vision Gmbh44%
Huvitz Co., Ltd.44%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Kerato refractometerMOPTIMYEASNAUTO REF/KERATOMETER36386TIANNUO / TNMEDIDESIGN RSIDESIGN ADVANCED WAVESCAN STUDIOWAVESCAN WAVEFRONT SYSTEMOpen-field Refraction SystemAUTO REFRACTOMETERHANDHELD REF / KERATOMETERHANDHELD REFRACTOMETERAUTO REF-TOPOGRAPHERAUTO REFKERATOMETERVisionix

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

FDA product codes

CodeNameDevices
HKORefractometer, Ophthalmic116
NCFAberrometer, ophthalmic10
LZSExcimer laser system7
HKORefractometer, ophthalmic7
HKXTonometer, Ac-Powered6
HKNRefractor, Manual, Non-Powered, Including Phoropter4

GMDN & GCC registration

  • GMDN code 36386 · non‑implantable
  • Single‑use 0% · sterile 2% · Rx‑only 54% · 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 automated ophthalmic refractometer products are registered in the US?

114 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Automated ophthalmic refractometer", from 25 companies. The largest labeler is Topcon Corporation with 12% of records.

Which FDA product codes apply?

HKO (Refractometer, Ophthalmic), NCF (Aberrometer, ophthalmic), LZS (Excimer laser system), HKO (Refractometer, 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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