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
- Free Sales Certificate - ElectroLarynx
- Free Sales Certificate - Atos Medical Product range
- MDSAP 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:
- Freevent® Accessories
- Freevent® Clothing Stoma Cover
- Freevent® Dressing
- Freevent® DualCare™
- Freevent® Neckband
- Freevent® Tracheal Tube Cleansing Jar
- Freevent® TubeBrush
- Freevent® XtraCare™
- Provox® ActiValve® System
- Provox® NID Voice Prosthesis System
- Provox® Vega™ System
- Provox®2 Voice Prosthesis System
- Provox® Accessories
- 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
- Trach Accessories
- Trach-HME Products
- Provox® Tracheofix
- Rhinology Products
- SinoJect System
- TheraBite System
- TympoVent Otologic Ventilation Tubes
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® 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
Provox® FreeHands
The Provox® FreeHands document bundle contains technical information for the following products:
- 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™
Provox® HME accessories
The Provox® HME accessories document bundle contains technical information for the following products:
- 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™
Provox® HME cassettes
The Provox® HME cassettes document bundle contains technical information for the following products:
- Provox® Coming Home®
- Provox® Living well
- Provox® Luna® HME
- Provox® Luna® Set
- Provox® Micron HME™
- Provox® XtraHME™
- Provox® XtraHME™ Spain
Provox® Laryngectomy products
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
Provox ® voice prosthesis
The Provox® voice prosthesis document bundle contains technical information for the following products:
- 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
Tracheostomy
The tracheostomy document bundle contains technical information for the following products:
- HME DigiTop O2
- Freevent® DualCare™ range
- Removal Aid
- Provox® TrachPhone® 30 pcs
- Provox® TrachPhone® 50 pcs
FreeVent
The Freevent document bundle contains technical information for the following products:
- 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
Other
Rhinology
The rhinology document bundle contains technical information for the following products:
- Nasal Splint
- Nasal Vent Splint
- Nasofix
- Septal Button
- Silatos Silicone Sheeting
- Silicone Sheeting
- SinoJect Instrument
- SinoJect Lavage Tube
- SinoJect Rods Set
- SinoJect Staytube
Therabite
The Therabite document bundle contains technical information for the following products:
- TheraBite® Jaw Motion Rehabilitation System
- TheraBite® Bite Pads
- TheraBite® Range of Motion Scale
- TheraBite® ActiveBand™ Kit
TympoVent
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.
- 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
- Latex free Statement
- Phthalate Free Statement
- Human & animal origin statement
5. Complaint Report
Use this for to report complaints regarding the performance of Atos Medical devices.
- TMP-0236-v.2.0-complaint-report.docx