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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

This page contains 5 sections:

  1. Company certificates: Includes valid Notified Body assessment certificates as well as Free Sales certificate.
  2. Declaration of conformity: The written statement and the declaration drawn up by Atos to demonstrate the fulfillment of applicable requirements.
  3. Technical information: Technical data and material data sheets contain product specific information such as reference numbers, classification, and other vital data.
  4. Product statements: This section contains generic statements, such as MRI safety, for the Atos Medical product range.
  5. 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.

1. 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:

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

2. 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 products
  • Freevent® Accessories
  • Freevent® Clothing Stoma Cover
  • Freevent® Dressing
  • Freevent® DualCare™
  • Freevent® Neckband
  • Freevent® Tracheal Tube Cleansing Jar
  • Freevent® TubeBrush
  • Freevent® XtraCare™
Download
Declaration of conformity - Provox Voice prosthesis and accessories
  • Provox® ActiValve® System
  • Provox® NID Voice Prosthesis System
  • Provox® Vega™ System
  • Provox®2 Voice Prosthesis System
  • Provox® Accessories
Download
Declaration of conformity - Provox HMEs, Adhesives, FreeHands, Lary products
  • Provox® Adhesives
  • Provox® FreeHands FlexiVoice™
  • Provox® FreeHands HME
  • Provox® HME Accessories
  • Provox® HME Cassettes
  • Provox® HMEs
  • Provox® Lary Products
  • Provox® Luna® Set
  • Provox® Life™ Adhesives
  • Provox® Life™ HMEs
  • Provox® Life™ Shower
Download
Declaration of conformity - Tracheostomy products
  • Trach Accessories
  • Trach-HME Products
  • Provox® Tracheofix
Download
Declaration of conformity - Other products
  • Rhinology Products
  • SinoJect System
  • TheraBite System
  • TympoVent Otologic Ventilation Tubes
Download

3. 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
  • Provox® Dilator
  • Provox® Flush
  • Provox® GuideWire
  • Provox® Measure
  • Provox® Measure Flanges
  • Provox® Pharynx Protector
  • Provox® Plug
  • Provox® Protector
  • Provox® Silicone Glue
  • Provox® Trocar
  • Provox® Twistlock
  • Provox® Vega Plug
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
  • Provox® FreeHands HME Cleaning and Storage Box
  • Provox® FreeHands HME
  • Provox® FreeHands HME Speech Valve Membrane
  • Provox® FreeHands Replacement Device
  • Provox® FreeHands Support Adhesive
  • Provox® FreeHands Support™
  • Provox® HME Cap™
Download

Provox® HME accessories

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

Provox® HME accessories
  • Provox® Adhesive Remover
  • Provox® Adhesive Strip™
  • Provox® Adhesives
  • Provox® Adhesives Spain
  • Provox® BasePlate Adaptor
  • Provox® Cleaning Towel
  • Provox® HME Cassette Adaptor
  • Provox® Luna® Adhesive
  • Provox® Luna® ShowerAid™
  • Provox® ShowerAid™
  • Provox® Skin Barrier
  • Provox® StabiliBase™ OptiDerm™
  • Provox® StabiliBase™
Download

Provox® HME cassettes

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

Provox® HME cassettes
  • Provox® Coming Home®
  • Provox® Living well
  • Provox® Luna® HME
  • Provox® Luna® Set
  • Provox® Micron HME™
  • Provox® XtraHME™
  • Provox® XtraHME™ Spain
Download

Provox® Laryngectomy products

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

Provox® Laryngectomy products
  • Provox® Fenestration Punch
  • Provox® LaryButton™
  • Provox® LaryButton™ Sizer Kit
  • Provox® LaryClip™
  • Provox® LaryTube™
  • Provox® LaryTube™ FR
  • Provox® LaryTube™ Sizer Kit
  • Provox® Swab
  • Provox® TubeBrush
  • Provox® TubeHolder
Download

Provox ® voice prosthesis

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

Provox® voice prosthesis
  • Provox® ActiValve
  • Provox® ActiValve Lubricant
  • Provox® NiD™
  • Provox® Vega™ (Insertion system)
  • Provox® Vega™ (Smart Inserter 2)
  • Provox® Vega™ Puncture Set
  • Provox® Voice Prosthesis
  • Provox® 2 Voice Prosthesis
Download

Tracheostomy

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

Tracheostomy
  • HME DigiTop O2
  • Freevent® DualCare™ range
  • Removal Aid
  • Provox® TrachPhone® 30 pcs
  • Provox® TrachPhone® 50 pcs
Download

FreeVent

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

Freevent
  • FreeVent clothing cover
  • Freevent tracheostomy dressings
  • Freevent NeckStraps
  • Freevent Neckbands
  • Freevent Pads
  • Freevent Tracheal Tube Cleansing Jar
  • Freevent Tracheal Tube Detergent Powder
  • Freevent TracheoFix
  • Freevent TubeBrush
  • Stoma Oil
Download

Other

Rhinology

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

Rhinology
  • Nasal Splint
  • Nasal Vent Splint
  • Nasofix
  • Septal Button
  • Silatos Silicone Sheeting
  • Silicone Sheeting
  • SinoJect Instrument
  • SinoJect Lavage Tube
  • SinoJect Rods Set
  • SinoJect Staytube
Download

Therabite

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

Therabite
  • TheraBite® Jaw Motion Rehabilitation System
  • TheraBite® Bite Pads
  • TheraBite® Range of Motion Scale
  • TheraBite® ActiveBand™ Kit
Download

TympoVent

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

TympoVent
  • Armstrong
  • Bevel Bobbin
  • Collar Button
  • Donaldson
  • Paparella with Tab
  • Reuter Bobbin
  • Shepard
  • Star Tube
  • Straight Tube
  • T-tube
  • Tübingen
Download

4. Product Statements

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

MRI safety information
  • Provox® Vega incl. Provox® Insertion S
  • Freevent® DualCare System
  • Provox® Accessories
  • Provox® ActiValve System
  • Provox® FreeHands HME system
  • Provox® NID Voice Prosthesis System
  • Provox® Pulmonary Rehabilitation Products
  • Provox® Trach-HME Products
  • Provox® Vega System
  • Provox® Voice Prosthesis System
  • Provox®2 Voice Prosthesis System
  • Rhinology Products
  • SinoJect System
  • TheraBite Jaw Motion Rehabilitation System
  • TympoVent Otologic Ventilation Tubes
Download
Generic product statements for the Atos Medical product range
  • Latex free Statement
  • Phthalate Free Statement
  • Human & animal origin statement
Download

5. Complaint Report

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

Template
  • TMP-0236-v.2.0-complaint-report.docx
Download