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 Declaration of conformities 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 & Provox® BasePlate Adaptor
Provox® Luna® Adhesive
Provox® ShowerAid™ & Provox® Luna® ShowerAid™
Provox® Silicone Glue
Provox® Skin Barrier & Provox® 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
Freevent® Dressing
Freevent® DualCare™
Freevent® Tracheal Tube Cleansing Jar
Freevent® XtraCare™ & Freevent® XtraCare™ Mini
Freevent® O2 Adaptor
Stoma Oil
TrachPhone®

Declaration of conformity - TympoVent Otologic Ventilation tubes
Armstrong
Bevel Bobbin
Collar Button
Donaldson
Paparella
Reuter Bobbin
Shepard
Star Tube
Straight Tube
T-Tube
Tübingen

Declaration of conformity - TheraBite system
TheraBite® ActiveBand™ Kit
TheraBite® Bite Pads
TheraBite® Jaw Motion Rehabilitation System™
TheraBite® Range of Motion Scale

Declaration of conformity – 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 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

The Provox Voice Rehabilitation document bundle contains technical information for the following products:
Provox® ActiValve®
Provox® ActiValve® Lubricant
Provox® Electrolarynx
Provox® NiD™
Provox® Vega™
Provox® Vega™ Puncture Set
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® O2 Adaptor Mini
Freevent® XtraCare™ & Freevent® XtraCare™ Mini
TrachPhone®

The Freevent document bundle contains technical information for the following products:
Freevent® Clothing Stoma Cover
Freevent® Dressings
Freevent® Dressing Softfoam
Freevent® Neckbands
Freevent® Pads
Provox® TracheoFix
Freevent® TubeBrush

The TheraBite document bundle contains technical information for the following products:
TheraBite® ActiveBand™ Kit
TheraBite® 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
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.