FDA.reportPublic FDA data

ENT diagnostic set

Definition
A collection of battery-powered devices intended to be used by a physician to perform an ear/nose/throat (ENT) clinical examination on a patient. The devices are typically enclosed in a dedicated case and may include an ophthalmoscope, an otoscope, a pharyngoscope, a dedicated interchangeable handle that contains the batteries, which may be rechargeable and common to all the examination devices, different attachments (e.g., ear specula, mirrors, tongue depressors), spare parts (e.g., light bulbs), and may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.
GUDID devices
24
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05055445967673SurtexSURTEX INSTRUMENTS LTD.OT-070-002026-05-12
05055445967680SurtexSURTEX INSTRUMENTS LTD.OT-072-012026-05-12
05055445967697SurtexSURTEX INSTRUMENTS LTD.OT-072-022026-05-12
05055445967703SurtexSURTEX INSTRUMENTS LTD.OT-072-032026-05-12
04048551071625n.a.Karl Storz GmbH & Co. KG207116212019-02-23
00842209131471NARNORTH AMERICAN RESCUE, LLC20-01012024-06-10
00842209131488NARNORTH AMERICAN RESCUE, LLC20-01182024-06-10
00842209131617NARNORTH AMERICAN RESCUE, LLCZZ-00422024-06-10
04045396002760econom® Vac. 2.7 V / XL 2.5 V, C-handleRudolf Riester GmbH20502021-01-28
04045396130593econom® Vac. 2.7 V / XL 2.5 V,Rudolf Riester GmbH2052-2002021-01-28
04045396130609econom® XL 2.5 V,Rudolf Riester GmbH2052-2012021-01-28
04045396130616econom® XL 3.5 V,Rudolf Riester GmbH2052-2022021-01-28
04045396130739econom® XL 3.5 V, C-handle,Rudolf Riester GmbH2054-2022021-01-28
04045396147140ri-scope® F.O. tongue blade holder LED 3.5 V,Rudolf Riester GmbH10574-3012021-01-28
04045396147157ri-scope® F.O. nasal speculum LED 3.5 V,Rudolf Riester GmbH10575-3012021-01-28
04045396147164ri-scope® F.O. light conductor LED 3.5 V,Rudolf Riester GmbH10576-3012021-01-28
04045396182639ri-scope® de luxe Oto- L3/Ophthalmo. L2, LED 3,5V/Rudolf Riester GmbH3774-2032021-01-28
04045396182646ri-vision with slit retinoscope XL/LED 3,5V, C hanRudolf Riester GmbH3794-2032021-01-28
04045396182660ri-vision with slit retinoscope XL/LED 3,5V/120V,Rudolf Riester GmbH3796-2032021-01-28
04045396211568ri-scope® E.N.T. L3 LED 2.5 V, C-handleRudolf Riester GmbH3760.0012021-01-28
04045396211599ri-scope® E.N.T. L3 LED 3.5 V/230 V,Rudolf Riester GmbH3761.0012021-01-28
04045396211605ri-scope® E.N.T. L3 LED 3.5 V/120 V,Rudolf Riester GmbH3762.0022021-01-28
04045396211612EliteVue XL Otos./L2 XL Ophthal. 2xC-Handle, 3,5VRudolf Riester GmbH3763.0012021-01-28
00851158007522Eli EzerU.S. OPHTHALMIC, L.L.C.EZ-WOT-2600 DC2018-03-28