Eli Ezer

FDA UDI

Class I (US FDA UDI)

by U.s. Ophthalmic, L.l.c.

Identity

Trade Name: Eli Ezer FDA UDI
Generic Name: ENT diagnostic set FDA UDI
Device Name: Ezer Diagnosis Wall Unit, 3.5 Led Ophthalmoscope and Otoscope with Dispenser, C battery and AC power FDA UDI
Model / Reference: EZ-WOT-2600 DC FDA UDI
Description: Ezer Diagnosis Wall Unit, 3.5 Led Ophthalmoscope and Otoscope with Dispenser, C battery and AC power FDA UDI

Identifiers

Primary DI / UDI-DI: 00851158007522 FDA UDI
FDA Product Code: EPY FDA UDI
HLJ FDA UDI
ERA FDA UDI
GMDN Term: ENT diagnostic set FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.1800 FDA UDI
886.1570 FDA UDI
874.4770 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

Yes

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: ENT diagnostic set

Eli Ezer by U.s. Ophthalmic, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENT diagnostic set.

econom® Vac. 2.7 V / XL 2.5 V, — Rudolf Riester GmbH & Co. KG · Class I
EliteVue XL Otos./L2 XL Ophthal. 2xC-Handle, 3, 5V — Rudolf Riester GmbH & Co. KG · Class I
ri-scope® de luxe Oto- L3/Ophthalmo. L2, LED 3, 5V/ — Rudolf Riester GmbH & Co. KG · Class I
ENT POCKET LIGHT — C F M TECHNOLOGIES INC · Class I
ri-vision with slit retinoscope XL/LED 3, 5V, C han — Rudolf Riester GmbH & Co. KG · Class I
ri-scope® F.O. nasal speculum LED 3.5 V, — Rudolf Riester GmbH & Co. KG · Class I
ri-vision with slit retinoscope XL/LED 3, 5V/120V, — Rudolf Riester GmbH & Co. KG · Class I
econom® XL 2.5 V, — Rudolf Riester GmbH & Co. KG · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: U.s. Ophthalmic, L.l.c.

Sources (1)

FDA UDI ed985006-25ab-4b4f-8376-9634716328d6 33 fields · synced May 30, 2026