Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015174190

FEI Number

3015174190

Entity Name

BIOMED ENT, INC

City/State/Country

Milwaukee, WI, US

Establishment Address

757 N Water St Ste 300, Milwaukee, WI 53202, US

Establishment Type(s)

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

Owner / Operator

BioMed ENT, Inc (Owner Number: 10084500)

Owner / Operator Contact Address

757 N Water Street suite 300, Milwaukee, WI 53202, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230142

PMA Number

N/A

All Registered Proprietary Names

Epi-Stop Nasal Gel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2023-11-29

Official Correspondent

Tonny Voermans

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioMed ENT, Inc

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3006306415	ORCA PRODUCTS LLC	Dothan, AL, US
3013517086	EQUIMEDICAL	Floriana, MT
3014653790	CHITOGEL LIMITED	Upper Hutt Wellington, NZ
3002789796	Legend Technical Services	Saint Paul, MN, US
3006113097	T-SCIENTIFIC INTERNATIONAL, INC.	SANTO DOMINGO Distrito Nacional, DO

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015174190. Last updated year: 2026. Please use registration number 3015174190 when referencing this establishment in official correspondence.