An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed)
| Company | Devices | Share |
|---|---|---|
| Heine Optotechnik Gmbh & Co. Kg | 83 | 39% |
| Zumax Medical Co., Ltd | 36 | 17% |
| Amico Diagnostic Incorporated | 34 | 16% |
| Rudolf Riester Gmbh | 25 | 12% |
| Keeler Limited | 10 | 5% |
| U.S. Ophthalmic, L.L.C. | 4 | 2% |
| D-Eye Srl | 4 | 2% |
| Jedmed Instrument Company | 3 | 1% |
| Gf Health Products, Inc. | 3 | 1% |
| Zhejiang Honsun Medical Technology Co., Ltd. | 2 | 1% |
| C F M Technologies Inc | 2 | 1% |
| Welch Allyn, Inc. | 2 | 1% |
Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| HLJ | Ophthalmoscope, Battery-Powered | 141 |
| ERA | Otoscope | 48 |
| HLI | Ophthalmoscope, Ac-Powered | 47 |
| HKL | Retinoscope, Ac-Powered | 4 |
| PJZ | Camera, Ophthalmic, General-Use | 4 |
| HLL | Monitor, Eye Movement | 2 |
Use these as the dimensions to specify in a tender line.
212 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Direct ophthalmoscope", from 15 companies. The largest labeler is Heine Optotechnik Gmbh & Co. Kg with 39% of records.
HLJ (Ophthalmoscope, Battery-Powered), ERA (Otoscope), HLI (Ophthalmoscope, Ac-Powered), HKL (Retinoscope, Ac-Powered)
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.