Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036471728

FEI Number

3036471728

Entity Name

AVIVOMED, INC

City/State/Country

Roseville, MN, US

Establishment Address

2896 Centre Pointe Dr, Roseville, MN 55113, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Avivomed, Inc (Owner Number: 10092939)

Owner / Operator Contact Address

2896 Centre Pointe Drive, Roseville, MN 55113, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNQ	Stimulator, Hypoglossal Nerve, Implanted, Apnea	Unknown	Class 3	N/A	2025-03-07

Official Correspondent

Kathleen Davis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avivomed, Inc

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2025	Inspire Medical Systems Inc.	3	Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Z-0041-2025	Inspire Medical Systems Inc.	3	Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Similar Registrations

Registration Number	Establishment Name	Location
3030499299	Inspire Medical Systems Inc	Golden Valley, MN, US
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3030384719	Nyxoah SA Milmort	Herstal Liege, BE
3008851924	PRONAT INDUSTRIES LTD.	Emek Hefer Ind. Park Haifa, IL
3030384402	NYXOAH INC	Summit, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036471728. Last updated year: 2026. Please use registration number 3036471728 when referencing this establishment in official correspondence.