Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027576156

FEI Number

3027576156

Entity Name

MEDIBEACON INC.

City/State/Country

Creve Coeur, MO, US

Establishment Address

425 N New Ballas Rd Ste 100, Creve Coeur, MO 63141, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MediBeacon Inc. (Owner Number: 10095100)

Owner / Operator Contact Address

425 N. New Ballas Road, Suite 100, Creve Coeur, MO 63141, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P230019

All Registered Proprietary Names

Lumitrace (relmapirazin) Injection MediBeacon Transdermal GFR System MediBeacon TGFR Monitor MediBeacon TGFR Disposable Ring MediBeacon TGFR Reusable Sensor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SDK	Transdermal Test For Assessment Of Glomerular Filtration Rate	Unknown	Class 3	N/A	2026-01-23

Official Correspondent

Richard Dorshow

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MediBeacon Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027576156. Last updated year: 2026. Please use registration number 3027576156 when referencing this establishment in official correspondence.