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IBEX Wireless LED Binocular Indirect Ophthalmoscope
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- IBEX Wireless LED Binocular Indirect Ophthalmoscope FDA UDI
- Generic Name
- Indirect binocular ophthalmoscope, line-powered FDA UDI
- Device Name
- IBEX Wireless LED Binocular Indirect Ophthalmoscope is a specialized microscope that provides stereoscopic, wide-angled, high resolution views of the entire fundus and overlying vitreous. Its optical principles and illumination system allows for visualization of the fundus regardless of high ametropia, hazy ocular media or central opacities. FDA UDI
- Model / Reference
- BIO FDA UDI
- Description
- IBEX Wireless LED Binocular Indirect Ophthalmoscope is a specialized microscope that provides stereoscopic, wide-angled, high resolution views of the entire fundus and overlying vitreous. Its optical principles and illumination system allows for visualization of the fundus regardless of high ametropia, hazy ocular media or central opacities. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869228000434 FDA UDI
- 510(k) Number
- K110205 FDA UDI
- FDA Product Code
- HLI FDA UDI
- GMDN Term
- Indirect binocular ophthalmoscope, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Indirect binocular ophthalmoscope, line-powered
IBEX Wireless LED Binocular Indirect Ophthalmoscope by Trevi Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indirect binocular ophthalmoscope, line-powered.
- Binocular Indirect Ophthalmoscope — Neitz Instruments Company, Ltd. · Class II
- HEINE OMEGA®500 — Heine Optotechnik GmbH & Co. KG · Class II
- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
- SLIMLINE BATTERY CHARGER & CARTON — KEELER LIMITED · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Trevi Technology
Sources (1)
- FDA UDI 51656a14-e465-47a9-b554-56be3f6658ce 35 fields · synced May 31, 2026