Eli Ezer

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name: Eli Ezer FDA UDI
Generic Name: Direct ophthalmoscope FDA UDI
Model / Reference: EZ-OPH-1800/HL FDA UDI

Identifiers

Primary DI / UDI-DI: 00851158007379 FDA UDI
510(k) Number: K052599 FDA UDI
FDA Product Code: HLL FDA UDI
HLJ FDA UDI
GMDN Term: Direct ophthalmoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1510 FDA UDI
886.1570 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: Direct ophthalmoscope

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

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HEINE mini 3000® LED F.O. Diagnostic Set — Heine Optotechnik GmbH & Co. KG · Class II
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JEDMED — JEDMED Instrument Company · Class II

Cleared under the same submission

K052599 also covers:

Eli Ezer — U.S. OPHTHALMIC, L.L.C.

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

Sources (1)

FDA UDI eb844da3-3214-4aaf-9f60-4b33142a4c10 33 fields · synced Jun 8, 2026