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Binocular Indirect Ophthalmoscope

FDA UDI

Class II (US FDA UDI)

by Neitz Instruments Company, Ltd.

Identity

Trade Name
Binocular Indirect Ophthalmoscope FDA UDI
Generic Name
Indirect binocular ophthalmoscope, line-powered FDA UDI
Device Name
Binocular indirect ophthalmoscope with a camera system to record images FDA UDI
Model / Reference
IO-a LED CAMERA FDA UDI
Description
Binocular indirect ophthalmoscope with a camera system to record images FDA UDI

Identifiers

Catalog Number
205021 FDA UDI
Primary DI / UDI-DI
04571328642303 FDA UDI
FDA Product Code
HLJ 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Indirect binocular ophthalmoscope, line-powered

Binocular Indirect Ophthalmoscope by Neitz Instruments Company, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indirect binocular ophthalmoscope, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neitz Instruments Company, Ltd.

Sources (1)

  • FDA UDI 36f090ad-0a29-42da-bd87-59fd01e2cd60 35 fields · synced May 30, 2026