Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012483804

FEI Number

3012483804

Entity Name

KERAMED INC.

City/State/Country

Placentia, CA, US

Establishment Address

710 Dunn Way, Placentia, CA 92870, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

KeraMed, Inc. (Owner Number: 10030689)

Owner / Operator Contact Address

710 Dunn Way, Placentia, CA 92870, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KeraKlear Artificial Cornea

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQM	Keratoprosthesis, Permanent Implant	Ophthalmic	Class 2	886.3400	2009-10-30

Official Correspondent

Yichieh Shiuey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KeraMed, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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3038274470	BRAINMATTERZ, INC	McKinney, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012483804. Last updated year: 2026. Please use registration number 3012483804 when referencing this establishment in official correspondence.