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
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:
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
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
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 & Coated
Freevent Dressing
Freevent DualCare
Freevent Tracheal Tube Cleansing Jar
Freevent XtraCare & XtraCare Mini
Freevent O2 Adaptor
Stoma Oil
TrachPhone
Declaration of conformity - Other products - Tympovent
TympoVent Otologic Ventilation Tubes
Declaration of conformity - Other products - Therabite
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
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
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
Stoma Sizing Guide
The Provox voice rehabilitation document bundle contains technical information for the following products:
Provox ActiValve
Provox ActiValve Lubricant
Provox Electrolarynx
Provox NiD
Provox Vega (Insertion system)
Provox Vega Puncture Set
Provox Vega (Smart Inserter 2)
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 XtraCare & XtraCare Mini
TrachPhone
The Freevent document bundle contains technical information for the following products:
Freevent clothing stoma cover
Freevent Dressings
Freevent Dressing Softfoam & Coated.
Freevent Neckbands
Stoma Oil
Freevent Pads
Freevent Tracheal Tube Cleansing Jar
Provox TracheoFix
Freevent TubeBrush
The Therabite document bundle contains technical information for the following products:
TheraBite ActiveBand KitTheraBite 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 with Tab
Reuter Bobbin
Shepard
Star Tube
Straight Tube
T-tube
Tübingen
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
Provox2 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
Use this for to report complaints regarding the performance of Atos Medical devices.
Template
TMP-0236-v.3.0-complaint-report.docx
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