Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035366119

FEI Number

3035366119

Entity Name

SBE MEDICAL INC.

City/State/Country

Comstock Park, MI, US

Establishment Address

320 Dodge Rd NE, Suite B, Comstock Park, MI 49321, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

SBE Medical Inc. (Owner Number: 10092519)

Owner / Operator Contact Address

320 Dodge Rd NE, Suite B, Comstock Park, MI 49321, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tibbe EUD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOA	Device, Paste-On For Incontinence, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-01-23

Official Correspondent

Dan Byers

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SBE Medical 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 3035366119. Last updated year: 2026. Please use registration number 3035366119 when referencing this establishment in official correspondence.