A pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the
| Company | Devices | Share |
|---|---|---|
| Zumax Medical Co., Ltd | 652 | 48% |
| Changzhou Sifary Medical Technology Co., Ltd. | 250 | 18% |
| Metrex Research, Llc | 184 | 14% |
| Surgitel | 65 | 5% |
| Peter Brasseler Holdings, Llc | 57 | 4% |
| Quality Aspirators, Inc. | 48 | 4% |
| Integra Lifesciences Production Corporation | 35 | 3% |
| Heine Optotechnik Gmbh & Co. Kg | 17 | 1% |
| Enova Illumination, Inc. | 14 | 1% |
| Rudolf Riester Gmbh | 10 | 1% |
| Vorotek Pty Ltd | 10 | 1% |
| Carl Zeiss Meditec Ag | 5 | 0% |
Company = labeler of record on GUDID. 17 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 |
|---|---|---|
| HJH | Loupe, Binocular, Low Power | 689 |
| FSP | Loupe, Diagnostic/Surgical | 392 |
| FSP | LOUPE, DIAGNOSTIC/SURGICAL | 120 |
| HJH | Loupe, binocular, low power | 84 |
| HOH | Spectacle, Operating (Loupe), Ophthalmic | 70 |
| HOI | Spectacle, Magnifying | 2 |
Use these as the dimensions to specify in a tender line.
1,357 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical binoculars, reusable", from 17 companies. The largest labeler is Zumax Medical Co., Ltd with 48% of records.
HJH (Loupe, Binocular, Low Power), FSP (Loupe, Diagnostic/Surgical), FSP (LOUPE, DIAGNOSTIC/SURGICAL), HJH (Loupe, binocular, low power)
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.