FDA.reportPublic FDA data

Direct ophthalmoscope

Definition
An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head.
GUDID devices
43
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04053755119998BETA 200 M2 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KG2,5 V2022-12-15
04053755120260K 180 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KG3,5 V2022-12-12
04053755182534BETA 200 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KG0002022-12-15
04053755182541BETA 200 S LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KG0002022-12-15
04053755203031BETA X OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGLED2025-07-17
04053755203567BETA X VET OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KG0002026-03-31
06945095540984zumaxZumax Medical Co., LTDDM6D2026-05-18
06945095543763zumaxZumax Medical Co., LTDDM6CE2026-05-20
06945095543770zumaxZumax Medical Co., LTDDM6C2026-05-20
06945095543848zumaxZumax Medical Co., LTDDM6UEP2026-05-20
06945095543879zumaxZumax Medical Co., LTDDM6BE2026-05-20
06945095543893zumaxZumax Medical Co., LTDDM6D2026-05-20
06945095543916zumaxZumax Medical Co., LTDDM6C2026-05-20
06945095543947zumaxZumax Medical Co., LTDDM6U2026-05-20
06945095543961zumaxZumax Medical Co., LTDDM6C2026-05-20
06945095543985zumaxZumax Medical Co., LTDDM6UE2026-05-20
06945095543992zumaxZumax Medical Co., LTDDM6BEP2026-05-20
06945095544104zumaxZumax Medical Co., LTDDM6D2026-05-20
06945095544135zumaxZumax Medical Co., LTDDM6F2026-05-20
06945095544166zumaxZumax Medical Co., LTDDM6DE2026-05-20
06945095544197zumaxZumax Medical Co., LTDDM6G2026-05-20
06945095544319zumaxZumax Medical Co., LTDDM6D2026-05-20
06945095544364zumaxZumax Medical Co., LTDDM6D2026-05-20
06945095544500zumaxZumax Medical Co., LTDDM6GE2026-05-20
06945095544548zumaxZumax Medical Co., LTDDM6DEP2026-05-20
06945095544555zumaxZumax Medical Co., LTDDM6D2026-05-20
06945095544685zumaxZumax Medical Co., LTDDM6DE2026-05-20
06945095545118zumaxZumax Medical Co., LTDDM6DE2026-05-20
06945095545125zumaxZumax Medical Co., LTDDM6DE2026-05-20
M368122731LabtronGF HEALTH PRODUCTS, INC.1227-32020-09-22
M368122741LabtronGF HEALTH PRODUCTS, INC.1227-42020-09-22
16972545090024JeashiaZhejiang Honsun Medical Technology Co., Ltd.HS-OTP10A2026-02-03
06972545090133JeashiaZhejiang Honsun Medical Technology Co., Ltd.HS-OTP10A2026-02-02
04053755202966BETA X OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGLED2025-07-17
04053755202232K 180 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KG3,52024-06-27
04053755119981BETA 200 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KG2,5 V2022-12-12
04053755120000BETA 200 S OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KG2,5 V2022-12-15
04053755120017K 180 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KG2,5 V2022-12-15
00697077003029Amico Diagnostic StationAmico Diagnostic IncorporatedDS-UV1-CLFL-DXX2024-05-02
00850038195335Eli EzerU.S. OPHTHALMIC, L.L.C.EZ-OPH-3600-Halogen-Lamp2024-04-03
00850038195342Eli EzerU.S. OPHTHALMIC, L.L.C.EZ-OPH-3600- Led Lamp2024-04-03
04030155000392EUROLIGHT E30, 2.5V ophthalmoscope with clic-closureKirchner & Wilhelm GmbH + Co KG01.21300.0012023-09-04
00697077002930Amico Diagnostic StationAmico Diagnostic IncorporatedDS-EDM-CLFL-XXX2022-02-02