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Regulatory information

On this page you will find information previously stored on the Extranet. The page is split into three 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. 

The three sections of this page
  • Company certificates: Includes valid Notified Body assessment certificates as well as Free Sales certificate.
  • 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.
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:

Certificates
  • EC Certificate
  • Free Sales Certificate - ElectroLarynx
  • Free Sales Certificate - Atos Medical Product range
  • ISO 13485:2016
  • MDSAP ISO 13485:2016
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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® accessories
  • 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
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Provox® FreeHands

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

Provox® FreeHands
  • 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™
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Provox® HME accessories

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

Provox® HME accessories
  • 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™
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Provox® HME cassettes

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

Provox® HME cassettes
  • Provox® Coming Home®
  • Provox® Living well
  • Provox® Luna® HME
  • Provox® Luna® Set
  • Provox® Micron HME™
  • Provox® XtraHME™
  • Provox® XtraHME™ Spain
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Provox® Laryngectomy products

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

Provox® Laryngectomy 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
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Provox ® voice prosthesis

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

Provox® voice prosthesis
  • 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
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Therabite

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

Therabite
  • TheraBite® Jaw Motion Rehabilitation System™
  • TheraBite® Bite Pads
  • TheraBite® Range of Motion Scale
  • TheraBite® ActiveBand™ Kit
Download
Product statements

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

MRI safety information
  • Provox® Vega™ incl. Provox® Insertion S
  • ProTrach® 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
Download
Generic product statements for the Atos Medical product range
  • Latex free Statement
  • Phthalate Free Statement
  • Human & animal origin statement
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