An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be
| Company | Devices | Share |
|---|---|---|
| Volk Optical Inc. | 23 | 11% |
| Forus Health Private Limited | 18 | 8% |
| Optovue, Inc. | 14 | 7% |
| Phoenix Clinical | 14 | 7% |
| Topcon Corporation | 13 | 6% |
| Kowa Company,Ltd. | 11 | 5% |
| Neolight Llc | 11 | 5% |
| Jedmed Instrument Company | 7 | 3% |
| Chongqing Sunkingdom Medical Instrument Co.,Ltd | 6 | 3% |
| Natus Medical Denmark Aps | 6 | 3% |
| Crystalvue Medical Corporation | 6 | 3% |
| Medimaging Integrated Solution Inc. | 6 | 3% |
Company = labeler of record on GUDID. 47 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 |
|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | 133 |
| PJZ | Camera, Ophthalmic, General-Use | 69 |
| HKI | Camera, ophthalmic, ac-powered | 13 |
| PJZ | Camera, ophthalmic, general-use | 9 |
| OBO | Tomography, Optical Coherence | 8 |
| NFJ | System, Image Management, Ophthalmic | 4 |
Use these as the dimensions to specify in a tender line.
215 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic fundus camera", from 47 companies. The largest labeler is Volk Optical Inc. with 11% of records.
HKI (Camera, Ophthalmic, Ac-Powered), PJZ (Camera, Ophthalmic, General-Use), HKI (Camera, ophthalmic, ac-powered), PJZ (Camera, ophthalmic, general-use)
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.