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
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 and MDD extension letter
EC Certificate
MDD extension letter; DMSP-5-PA-MDR-32-A1 Notified Body Confirmation Letter
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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
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
Provox2 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 (including Provox StabiliBase and Provox StabiliBase OptiDerm)
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 Tracheofix
Provox Wipes
Declaration of conformity - Provox HME Cassettes
Provox Coming Home
Provox Luna HME
Provox Luna Set
Provox Micron HME
Provox XtraHME
Declaration of conformity - Provox Laryngectomy Products
Provox FenestrationPunch
Provox LaryButton
Provox LaryButton Sizer Kit
Provox Life LaryButton
Provox LaryClip
Provox LaryTube
Provox LaryTube Sizer Kit
Provox Life LaryTube
Provox Swab
Provox TubeBrush
Provox TubeHolder
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 Shower
Provox Life Sample Packs
(For Provox Life LaryTube and Provox Life LaryButton see section Provox Laryngectomy Products).
Declaration of conformity - Tracheostomy products
Freevent Clothing Stoma Cover
Freevent Dressing
Freevent Dressing Pad
Freevent Dressing Softfoam
Freevent DualCare
Freevent HME 15
Freevent HME 22
Freevent Neckband
Freevent Tracheal Tube Cleansing Jar
Freevent TubeBrush
Freevent XtraCare (including Freevent XtraCare Mini)
Freevent O2 Adaptor (including Freevent O2 Adaptor Mini)
HME DigiTop O2
Stoma Oil
TrachPhone
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
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 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
MRI safety information is stated in the instructions for use, if applicable for the product. Information regarding latex and biological origin is stated in the Technical Information sheet for the product.
Use this for to report complaints regarding the performance of Atos Medical devices.
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