A mobile assembly of devices designed to use near infrared (NIR) LED light aimed into the eye to acquire, process, display and save in vivo depth-resolved images of anterior and posterior ocular tissue microstructures in clinical and perioperative examination
| Company | Devices | Share |
|---|---|---|
| Optovue, Inc. | 54 | 68% |
| Topcon Corporation | 7 | 9% |
| Heidelberg Engineering Gmbh | 7 | 9% |
| Carl Zeiss Meditec, Inc. | 4 | 5% |
| Carl Zeiss Meditec Ag | 3 | 4% |
| Huvitz Co., Ltd. | 2 | 2% |
| Tomey Corporation. | 1 | 1% |
| Leica Instruments (Singapore) Pte Limited | 1 | 1% |
| Costruzioni Strumenti Oftalmici C.S.O. Srl | 1 | 1% |
Company = labeler of record on GUDID. 9 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 |
|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | 49 |
| OBO | Tomography, Optical Coherence | 46 |
| OBO | Tomography, optical coherence | 18 |
| MYC | Ophthalmoscope,Laser,Scanning | 12 |
| HKI | Camera, Ophthalmic, Ac-Powered | 7 |
| HKI | Camera, ophthalmic, ac-powered | 6 |
Use these as the dimensions to specify in a tender line.
80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic spectral-domain optical coherence tomography system", from 9 companies. The largest labeler is Optovue, Inc. with 68% of records.
HLI (Ophthalmoscope, Ac-Powered), OBO (Tomography, Optical Coherence), OBO (Tomography, optical coherence), MYC (Ophthalmoscope,Laser,Scanning)
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.