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:

• 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 fulfillment 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.

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

Free Sales Certificate - Atos Medical Product range - MDR Devices
Free Sales Certificate - Atos Medical Product range - MDR devices

Free Sales Certificate - Atos Medical Product range
Free Sales Certificate - Atos Medical Product range - Class II devices

MDSAP ISO 13485:2016
MDSAP ISO 13485:2016

ISO 13485:2016
ISO 13485:2016

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 - Provox Voice Rehabilitation
Provox® ActiValve® System
Provox® Electrolarynx
Provox® NID Voice Prosthesis System
Provox® Vega™ System
Provox®2 Voice Prosthesis System

Declaration of conformity - Provox Accessories
Provox Brush
Provox Capsule
Provox Dilator 17 & 20
Provox Dilator
Provox Flush
Provox Guidewire
Provox Measure
Provox Plug
Provox Protector
Provox TwistLock
Provox Vega Plug
Provox XtraFlange

Declaration of conformity - Provox Freehands
Provox FreeHands Flexivoice
Provox FreeHands HME
Provox FreeHands Support
Provox Freehands Support Adhesive
Provox HME Cap

Declaration of conformity - Provox HME Accessories
Provox Adhesive Remover
Provox Adhesive Strip
Provox Adhesives
Provox Cleaning Towel
Provox HME Cassette Adaptor & BasePlate Adaptor
Provox Luna Adhesive
Provox ShowerAid & Luna ShowerAid
Provox Silicone Glue
Provox Skin Barrier & Wipes
Provox StabiliBase OptiDerm
Provox StabiliBase
Provox Tracheofix

Declaration of conformity - Provox HME Cassettes
Provox Coming Home
Provox HMEs
Provox Luna Set
Provox Micron HME

Declaration of conformity - Provox Laryngectomy Products
Provox FenestrationPunch
Provox LaryButton & Provox Life LaryButton
Provox LaryButton Sizer Kit
Provox LaryClip
Provox LaryTube & Provox Life LaryTube
Provox LaryTube Sizer Kit
Freevent Neckband & Provox TubeHolder
Freevent TubeBrush & Provox TubeBrush
Provox Swab
Stoma Sizing Guide

Declaration of conformity - Provox Life Products
Provox Life Adhesives
Provox Life BasePlate Adaptor
Provox Life Experience Packs
Provox Life FreeHands HME
Provox Life HME
Provox Life LaryTube
Provox Life Shower
Provox Life Sample Packs
(See Provox Life LaryTube & Provox Life LaryButton under section Provox Laryngectomy Products)

Declaration of conformity - Tracheostomy products
Freevent Clothing Stoma Cover
HME DigiTop O2
Freevent Dressing Softfoam & Coated
Freevent Dressing
Freevent DualCare
Freevent Tracheal Tube Cleansing Jar
Freevent XtraCare & XtraCare Mini
Freevent O2 Adaptor
Stoma Oil
TrachPhone

Declaration of conformity - Other products - Tympovent
TympoVent Otologic Ventilation Tubes

Declaration of conformity - Other products - Therabite
Therabite System

Declaration of conformity – Other products – iSKiA products
Pflegekanülen
PRIMA-RESP
PRIMA-SAFE
PRIMA-SMOOTH
PRIMA-STOM II OIL
PRIMA-STOM II PED
PRIMA-STOM SMOOTH
SILKO-VENT SOFT
SILKO-VENT SOFT O2
SILKO-VENT UNI
SILKO-VENT UNI O2
Trachealkanülen
VITALO

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.

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

Provox® Brush
Provox® Capsule
Provox® Dilator 17 & 20
Provox® Dilator
Provox® Flush
Provox® GuideWire
Provox® Measure
Provox® Plug
Provox® Protector
Provox® Twistlock
Provox® Vega Plug
Provox® XtraFlange

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

Provox® FreeHands
Provox® FreeHands FlexiVoice™
Provox® HME Cap™
Provox® FreeHands HME Cassette
Provox® FreeHands Support™
Provox® FreeHands Support Adhesive

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

Provox® Adhesives
Provox® Adhesive Remover
Provox® Adhesive Strip™
Provox® BasePlate Adaptor
Provox® Cleaning Towel
Provox® HME Cassette Adaptor
Provox® Luna® Adhesive
Provox® Luna® ShowerAid™
Provox® ShowerAid™
Provox® Silicone Glue
Provox® Skin Barrier
Provox® StabiliBase™
Provox® StabiliBase™ OptiDerm™

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

Provox® Coming Home®
Provox® Luna® HME
Provox® Luna® Set
Provox® Micron HME™
Provox® XtraHME™

The Provox® laryngectomy document bundle contains technical information for the following 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
Stoma Sizing Guide

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

Provox® ActiValve
Provox® ActiValve Lubricant
Provox Electrolarynx
Provox® NiD™
Provox® Vega™ (Insertion system)
Provox® Vega™ Puncture Set
Provox® Vega™ (Smart Inserter 2)
Provox® 2 Voice Prosthesis

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

Provox Life Adhesives
Provox Life BasePlate Adaptor
Provox Life Experience Packs
Provox Life FreeHands HME
Provox Life HME
Provox Life LaryButton
Provox Life LaryTube
Provox Life Sample Packs
Provox Life Shower
Stoma Sizing Guide

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

HME DigiTop O2
Freevent® DualCare™ range
Freevent O2 Adaptor
Freevent XtraCare & XtraCare Mini
TrachPhone

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

Freevent clothing stoma cover
Freevent Dressings
Freevent Dressing Softfoam & Coated.
Freevent Neckbands
Stoma Oil
Freevent Pads
Freevent Tracheal Tube Cleansing Jar
Provox TracheoFix
Freevent TubeBrush

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

TheraBite® ActiveBand™ KitTheraBite® Bite Pads
TheraBite® Jaw Motion Rehabilitation System
TheraBite® Range of Motion Scale

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

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

4. Product Statements

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

MRI safety information
Provox® Accessories
Provox® ActiValve System
Freevent® DualCare System
Provox® FreeHands HME system
Provox® NID Voice Prosthesis System
Provox® Pulmonary Rehabilitation Products
Provox® Trach-HME Products
Provox® Vega System
Provox® Vega incl. Provox® Insertion S
Provox® Voice Prosthesis System
Provox®2 Voice Prosthesis System
Rhinology Products
TheraBite Jaw Motion Rehabilitation System
TympoVent Otologic Ventilation Tubes

Generic product statements for the Atos Medical product range
Latex free Statement
Human & animal origin statement
Phthalate Free Statement

5. Complaint Report

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