RETeval™

FDA UDI

Class I (US FDA UDI)

by LKC Technologies

Identity

Trade Name: RETeval™ FDA UDI
Generic Name: Electroretinograph electrode FDA UDI
Device Name: RETeval visual electrophysiology system - DR model for non-USA FDA UDI
Model / Reference: RETeval-DR - ROW FDA UDI
Description: RETeval visual electrophysiology system - DR model for non-USA FDA UDI

Identifiers

Catalog Number: RETEval - DR FDA UDI
Primary DI / UDI-DI: 00857901006637 FDA UDI
510(k) Number: K142567 FDA UDI
FDA Product Code: HLG FDA UDI
GXY FDA UDI
GWE FDA UDI
GMDN Term: Electroretinograph electrode FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.1700 FDA UDI
882.1320 FDA UDI
882.1890 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electroretinograph Electroretinograph electrode

RETeval™ by LKC Technologies — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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RETeval™ — LKC Technologies · Class I
RETeval™ — LKC Technologies · Class I

Cleared under the same submission

K142567 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 I	Pending data

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Manufacturer

Manufacturer: LKC Technologies

Sources (1)

FDA UDI 768a150a-ed89-4ecc-b5c5-25d391a9fbe4 36 fields · synced May 30, 2026