Consulting Wallah › Device Explorer › Ophthalmic › Indirect binocular ophthalmoscope
Device Explorer · FDA GUDID · GMDN 46790

Indirect binocular ophthalmoscope

An electrically-powered, head-worn, ophthalmic instrument designed to be held arm’s length from the patient to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, vitreous] using the examiner’s two eyes simulta

US‑registered devices73in commercial distribution
Companies7labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription26%Rx‑only share
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Share of device records

Heine Optotechnik Gmbh & Co. Kg3142%
Keeler Limited1926%
Sontec Instruments, Inc.1521%
Welch Allyn, Inc.45%
Zumax Medical Co., Ltd23%
Neitz Instruments Co.,Ltd.11%
U.S. Ophthalmic, L.L.C.11%

Top labelers

CompanyDevicesShare
Heine Optotechnik Gmbh & Co. Kg3142%
Keeler Limited1926%
Sontec Instruments, Inc.1521%
Welch Allyn, Inc.45%
Zumax Medical Co., Ltd23%
Neitz Instruments Co.,Ltd.11%
U.S. Ophthalmic, L.L.C.11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

zumaxVANTAGE PLUS DIGITAL/ANALOGUE FIXED FOCUS KITAPI CORDED WITH BLUE FILTER ASSYLED SLIMLINE STUDENT KITSpectra Iris & small black frameSpectra Iris & large black frameSpectra Iris & regular black frameAPI LED Wireless & Slimline chargerVantage Plus LED CordedVANTAGE+ LED SLIMLINE KIT AVantage Plus LED Slimline & ChargerVantage Plus Digital KitSMARTPACKWALLPACKWIRELESS INDIRECT CHARGER IN CARTONPOWER PACK ASSY

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

FDA product codes

CodeNameDevices
HLJOphthalmoscope, Battery-Powered58
HLIOphthalmoscope, Ac-Powered19
HLIOphthalmoscope, ac-powered7
HJLLens, Condensing, Diagnostic3
HLJOphthalmoscope, battery-powered2
HKLRetinoscope, Ac-Powered1

GMDN & GCC registration

  • GMDN code 46790 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 26% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 2

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

How many indirect binocular ophthalmoscope products are registered in the US?

73 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Indirect binocular ophthalmoscope", from 7 companies. The largest labeler is Heine Optotechnik Gmbh & Co. Kg with 42% of records.

Which FDA product codes apply?

HLJ (Ophthalmoscope, Battery-Powered), HLI (Ophthalmoscope, Ac-Powered), HLI (Ophthalmoscope, ac-powered), HJL (Lens, Condensing, Diagnostic)

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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