Consulting Wallah › Device Explorer › Ophthalmic › Ophthalmic examination slit lamp
Device Explorer · FDA GUDID · GMDN 35148

Ophthalmic examination slit lamp

An electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflecti

US‑registered devices410in commercial distribution
Companies36labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription24%Rx‑only share
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Share of device records

Keeler Limited6817%
Topcon Corporation3910%
Haag-Streit Ag389%
Costruzioni Strumenti Oftalmici C.S.O. Srl369%
U.S. Ophthalmic, L.L.C.338%
Shanghai Mediworks Precision Instruments Co.,Ltd.328%
Chongqing Sunkingdom Medical Instrument Co.,Ltd225%
Luneau Technology Operations154%

Top labelers

CompanyDevicesShare
Keeler Limited6817%
Topcon Corporation3910%
Haag-Streit Ag389%
Costruzioni Strumenti Oftalmici C.S.O. Srl369%
U.S. Ophthalmic, L.L.C.338%
Shanghai Mediworks Precision Instruments Co.,Ltd.328%
Chongqing Sunkingdom Medical Instrument Co.,Ltd225%
Luneau Technology Operations154%
Oculus Optikgeräte Gesellschaft Mit Beschränkter Haftung143%
Lianyungang Tiannuo Optical Instrument Co., Ltd.123%
Kowa Company,Ltd.123%
Inami & Co., Ltd.113%

Company = labeler of record on GUDID. 36 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SYLOphthalmic Slit Lamp MicroscopeMOPTIMYEASNMicroclearNATomeyEssilorMediWorksRodenstockMediworksTIANNUO / TNMEDClement Clarke OphthalmicKeeler Kapture Lite to View Plus UpgradeKeeler Kapture Lite to View Std UpgradeKeeler Kapture Lite to Digital Upgrade

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

FDA product codes

CodeNameDevices
HJOBiomicroscope, Slit-Lamp, Ac-Powered327
PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt70
HJOBiomicroscope, slit-lamp, ac-powered33
KQMCamera, Surgical And Accessories14
HKICamera, Ophthalmic, Ac-Powered6
HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED6

GMDN & GCC registration

  • GMDN code 35148 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 24% · 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

Width (Millimeter) · 38Depth (Millimeter) · 38Height (Millimeter) · 38Weight (Kilogram) · 27Weight (Gram) · 11

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

How many ophthalmic examination slit lamp products are registered in the US?

410 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic examination slit lamp", from 36 companies. The largest labeler is Keeler Limited with 17% of records.

Which FDA product codes apply?

HJO (Biomicroscope, Slit-Lamp, Ac-Powered), PUE (Biomicroscope, Slit-Lamp, Ac-Powered, Exempt), HJO (Biomicroscope, slit-lamp, ac-powered), KQM (Camera, Surgical And Accessories)

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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