identifeye Camera System, reconditioned

FDA UDI

Class II (US FDA UDI)

by Identifeye Health Inc.

Identity

Trade Name: identifeye Camera System, reconditioned FDA UDI
Generic Name: Ophthalmic fundus camera FDA UDI
Device Name: The identifeye Camera System is a fundus ophthalmic camera reconditioned. FDA UDI
Model / Reference: 850-30004-00 FDA UDI
Description: The identifeye Camera System is a fundus ophthalmic camera reconditioned. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850067214281 FDA UDI
FDA Product Code: PJZ FDA UDI
GMDN Term: Ophthalmic fundus camera FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1120 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Ophthalmic fundus camera

identifeye Camera System, reconditioned by Identifeye Health Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Identifeye Health Inc.

Sources (1)

FDA UDI 10d0d15f-bf75-4e43-b188-a931c1715b29 34 fields · synced May 31, 2026