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Regulatory information

On this page you will find information previously stored on the Extranet. The page is split into five sections each containing the parts of the information from the Extranet. If you have any questions do not hesitate to contact our Quality Assurance department directly at quality.se@atosmedical.com. 

The five sections of the page
  • Company certificates: Includes valid Notified Body assessment certificates as well as Free Sales certificate.
  • Declaration of conformity: The written statement and the declaration drawn up by Atos to demonstrate the fulfilment of applicable requirements.
  • Technical information: Technical data and material data sheets contain product specific information such as reference numbers, classification and other vital data.
  • Product statements: This section contains generic statements, such as MRI safety, for the Atos Medical product range.
  • Complaint report: This is the template that shall be used to ensure that as much information as possible is recorded and to simplify the reporting of complaints on Atos Medical products.
Company certificates

Atos always prioritizes product safety and quality from the early stages of designing a new product, through production, and until the end of its life cycle. We maintain a certified Quality Management System based on ISO 13485 in compliance with regulatory requirements everywhere we operate.

We analyze, evaluate, and control the product risks related to our products, and maintain a post market surveillance process where all product safety and quality concerns are systematically documented to ensure timely reporting to authorities and give important input for improvement of the product quality.

The Certificates document bundle contains the following certificates:

Certificates
  • EC Certificate
  • Free Sales Certificate - ElectroLarynx
  • Free Sales Certificate - Atos Medical Product range
  • ISO 13485:2016
  • MDSAP ISO 13485:2016
Download
Declaration of conformity

A declaration of conformity is the written statement and the declaration drawn up by Atos to demonstrate the fulfilment of applicable requirements relating to a product bearing the CE marking we have manufactured. The declaration is in respect of all acts applicable to the product containing all information required for the identification of harmonized legislation to which the declaration relates.

The Declaration of conformity document bundle contains technical information for the following products:

Declaration of conformity
  • FreeVent Accessories
  • ProTrach® DualCare System
  • ProTrach® XtraCare System
  • Provox® Accessories
  • Provox® ActiValve System
  • Provox® FreeHands HME
  • Provox® HME Accessories
  • Provox® HME Cassettes
  • Provox® Lary Products
  • Provox® NID Voice Prosthesis System
  • Provox® Trach-HME Products
  • Provox® Vega System
  • Provox® Voice Prosthesis System
  • Provox®2 Voice Prosthesis System
  • Rhinology Products
  • SinoJect System
  • TheraBite System
  • TympoVent Otologic Ventilation Tubes
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Technical information

Technical data and material data sheets contain product specific information such as reference numbers, classification and other vital data.

New documents are issued when changes are made to the products.

Note! Technical Information is maintained throughout the intended lifetime of a device even if the device has been discontinued.

Provox ®

The Provox® document bundle contains technical information for the following products:

Provox® accessories
  • Provox® Brush
  • Provox® Capsule
  • Provox® Dilator 17 & 20
Download

Provox® FreeHands

The Provox® FreeHands document bundle contains technical information for the following products:

Provox® FreeHands
  • Provox® FreeHands Adjustment Kit
  • Provox® FreeHands FlexiVoice™
  • Provox® FreeHands HME Cassette
Download

Provox® HME accessories

The Provox® HME accessories document bundle contains technical information for the following products:

Provox® HME accessories
  • Provox® Adhesive Remover
Download

Provox® HME cassettes

The Provox® HME cassettes document bundle contains technical information for the following products:

Provox® HME cassettes
  • Provox® Coming Home®
Download

Provox® Laryngectomy products

The Provox® laryngectomy document bundle contains technical information for the following products:

Provox® Laryngectomy products
  • Provox® Fenestration Punch
Download

Provox ® voice prosthesis

The Provox® voice prosthesis document bundle contains technical information for the following products:

Provox® voice prosthesis
  • Provox® ActiValve
Download

Tracheostomy

The tracheostomy document bundle contains technical information for the following products:

Tracheostomy
  • HME DigiTop O2
Download

FreeVent

The Freevent document bundle contains technical information for the following products:

Freevent
  • FreeVent clothing cover
Download

Other

Rhinology

The rhinology document bundle contains technical information for the following products:

Rhinology
  • Nasal Splint
Download

Therabite

The Therabite document bundle contains technical information for the following products:

Therabite
  • TheraBite® Jaw Motion Rehabilitation System
Download

TympoVent

The TympoVent document bundle contains technical information for the following products:

TympoVent
  • Armstrong
Download
Product statements

MRI safety and other information statements for the Atos Medical product range.

MRI safety information
  • Provox® Vega incl. Provox® Insertion S
Download
Generic product statements for the Atos Medical product range
  • Latex free Statement
Download
Complaint report

Use this for to report complaints regarding the performance of Atos Medical devices.

Template
  • QMC-831-103-en_Complaint_report
Download