An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source inte
| Company | Devices | Share |
|---|---|---|
| Welch Allyn, Inc. | 116 | 30% |
| Rudolf Riester Gmbh | 41 | 11% |
| Jedmed Instrument Company | 31 | 8% |
| Heine Optotechnik Gmbh & Co. Kg | 30 | 8% |
| Luxamed Gmbh & Co. Kg | 27 | 7% |
| Prosidio Llc | 26 | 7% |
| Bv Medical | 18 | 5% |
| Zumax Medical Co., Ltd | 15 | 4% |
| Firefly Global | 15 | 4% |
| Kirchner & Wilhelm Gmbh + Co Kg | 10 | 3% |
| Zhejiang Honsun Medical Technology Co., Ltd. | 8 | 2% |
| Shenzhen Teslong Technology Co.,Ltd | 7 | 2% |
Company = labeler of record on GUDID. 31 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 |
|---|---|---|
| ERA | Otoscope | 287 |
| ERA | OTOSCOPE | 131 |
| EQH | SOURCE, CARRIER, FIBEROPTIC LIGHT | 5 |
| HLJ | Ophthalmoscope, Battery-Powered | 5 |
| LDE | Stethoscope, Manual | 3 |
| DXQ | Blood Pressure Cuff | 3 |
Use these as the dimensions to specify in a tender line.
384 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Otoscope, direct", from 31 companies. The largest labeler is Welch Allyn, Inc. with 30% of records.
ERA (Otoscope), ERA (OTOSCOPE), EQH (SOURCE, CARRIER, FIBEROPTIC LIGHT), HLJ (Ophthalmoscope, Battery-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.