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 - MDR devices
- Free Sales Certificate - Atos Medical Product range - Class II devices
- 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:
- Provox® ActiValve® System
- Provox® Electrolarynx
- Provox® NID Voice Prosthesis System
- Provox® Vega™ System
- Provox®2 Voice Prosthesis System
- 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
- Provox FreeHands Flexivoice
- Provox FreeHands HME
- Provox FreeHands Support
- Provox Freehands Support Adhesive
- Provox HME Cap
- 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
- Provox Coming Home
- Provox HMEs
- Provox Luna Set
- Provox Micron HME
- 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
- 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)
- 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
- TympoVent Otologic Ventilation Tubes
- 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.
Provox ® Life products
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® Plug
- Provox® Protector
- Provox® Twistlock
- Provox® Vega Plug
- Provox® XtraFlange
Provox® FreeHands
Provox® FreeHands
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
Provox® HME accessories
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™
Provox® HME cassettes
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™
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™ Puncture Set
- Provox® Vega™ (Smart Inserter 2)
- Provox® 2 Voice Prosthesis
Provox ® Life products
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
Tracheostomy
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
FreeVent
The Freevent document bundle contains technical information for the following products:
- Freevent clothing stoma cover
- Freevent Dressings
- Freevent Dressing Softfoam & Coated.
- Freevent NeckStraps
- Freevent Neckbands
- Stoma Oil
- Freevent Pads
- Freevent Tracheal Tube Cleansing Jar
- Provox TracheoFix
- Freevent TubeBrush
Other
Therabite
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
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® 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
- 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.
- TMP-0236-v.3.0-complaint-report.docx