A collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an o
| Company | Devices | Share |
|---|---|---|
| American Diagnostic Corp | 1,333 | 82% |
| Welch Allyn, Inc. | 233 | 14% |
| Rudolf Riester Gmbh | 48 | 3% |
| North American Rescue, Llc | 3 | 0% |
| Evonos Gmbh & Co. Kg | 2 | 0% |
| Medline Industries, Inc. | 2 | 0% |
Company = labeler of record on GUDID. 6 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 | 1,092 |
| ERA | Otoscope | 697 |
| ERA | OTOSCOPE | 109 |
| DXQ | Blood Pressure Cuff | 97 |
| IBJ | Light, Microscope | 83 |
| HLI | Ophthalmoscope, ac-powered | 80 |
Use these as the dimensions to specify in a tender line.
1,621 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic/otologic diagnostic set", from 6 companies. The largest labeler is American Diagnostic Corp with 82% of records.
HLJ (Ophthalmoscope, Battery-Powered), ERA (Otoscope), ERA (OTOSCOPE), DXQ (Blood Pressure Cuff)
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.