Ellex

FDA UDI

Class II (US FDA UDI)

by Ellex Medical Pty Ltd

Identity

Trade Name: Ellex FDA UDI
Generic Name: Ophthalmic ultrasound imaging system FDA UDI
Device Name: FGOODS, EYEONE FDA UDI
Model / Reference: EYEONE FDA UDI
Description: FGOODS, EYEONE FDA UDI

Identifiers

Primary DI / UDI-DI: 09342395000274 FDA UDI
510(k) Number: K103608 FDA UDI
FDA Product Code: IYO FDA UDI
ITX FDA UDI
GMDN Term: Ophthalmic ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
892.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic ultrasound imaging system

Ellex by Ellex Medical Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic ultrasound imaging system.

A-scan probe — Nidek, Inc. · Class II
ArcScan Insight 100 — Arcscan, Inc. · Class II
Ultrasonic A/B Scanner for Ophthalmology — Meda , Ltd. · Class II
Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
LIGHTSonic B UBM — Light-Med(Usa), Inc. · Class II
Ophthalmic Ultrasound Examination Instrument — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class II
B-scan Plus- VET — ACCUTOME, INC. · Class II
A-scan probe — Nidek, Inc. · Class II

Cleared under the same submission

K103608 also covers:

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: Ellex Medical Pty Ltd

Sources (1)

FDA UDI de38a9cd-b38b-49b6-a9af-ce352bdb2f24 35 fields · synced Jun 1, 2026