A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to cre
| Company | Devices | Share |
|---|---|---|
| Novo Surgical, Inc. | 173 | 7% |
| Avalign Technologies, Inc. | 164 | 7% |
| Integra Lifesciences Production Corporation | 164 | 7% |
| Aspen Surgical Products, Inc. | 156 | 6% |
| Bear-Ent, Llc | 125 | 5% |
| Surgical Direct, Inc. | 123 | 5% |
| Boss Instruments, Ltd., Inc. | 121 | 5% |
| Br Surgical, Llc | 105 | 4% |
| Sklar Corporation | 100 | 4% |
| Fentex Medical Gmbh | 86 | 4% |
| Jedmed Instrument Company | 86 | 4% |
| Rz-Medizintechnik Gmbh | 81 | 3% |
Company = labeler of record on GUDID. 46 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 |
|---|---|---|
| EPY | SPECULUM, ENT | 1,278 |
| EPY | Speculum, Ent | 1,015 |
| EGN | SCISSORS, SURGICAL TISSUE, DENTAL | 125 |
| ERA | Otoscope | 72 |
| HNC | Specula, ophthalmic | 45 |
| LRC | INSTRUMENT, ENT MANUAL SURGICAL | 34 |
Use these as the dimensions to specify in a tender line.
2,417 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ear speculum, reusable", from 46 companies. The largest labeler is Novo Surgical, Inc. with 7% of records.
EPY (SPECULUM, ENT), EPY (Speculum, Ent), EGN (SCISSORS, SURGICAL TISSUE, DENTAL), ERA (Otoscope)
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.