Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006267333

FEI Number

3006267333

Entity Name

MONTEX AB

City/State/Country

Jamjoe Blekinge, SE

Establishment Address

Montex AB, Vallevagen 6, Jamjoe Blekinge 37373, SE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Montex AB (Owner Number: 10082065)

Owner / Operator Contact Address

Montex AB, Vallevagen 6, Jämjö, SE-K 37373, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Atos Medical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESE	Larynx, Artificial (Battery-Powered)	Ear, Nose, Throat	Class 1	874.3375	2021-06-11

Official Correspondent

Eric Ullstrom

US Agent Details

Jason Woehrle Business: COLOPLAST CORP. Email: usjawo@coloplast.com Phone: (612) 7302063

Related Public Records

Same Entity

Montex AB

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 3006267333. Last updated year: 2026. Please use registration number 3006267333 when referencing this establishment in official correspondence.