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Regulatorische Informationen

Auf dieser Seite finden Sie das Unternehmenszertifikat, die Konformitätserklärung, die technischen Informationen/Produktdatenblatt, die Produkterklärung und den Beschwerdebericht.


Wenn Sie Fragen haben, wenden Sie sich bitte direkt an die Abteilung Regulatory Affairs unter quality.se@atosmedical.com or regulatory-tracoe@atosmedical.com.

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    Atos Medical ISO 13485:2016
    Atos Medical MDSAP ISO 13485:2016
    Atos Medical EC Certificate
    Atos Medical MDD extension letter
    Complaint report
    DoC Freevent Clothing Stoma Cover
    DoC Freevent Dressing
    DoC Freevent Dressing Foam
    DoC Freevent Dressing Softfoam
    DoC Freevent DualCare
    DoC Freevent HME 15
    DoC Freevent HME 22
    DoC Freevent Neckband
    DoC Freevent O2 Adaptor
    DoC Freevent TubeBrush
    DoC Freevent XtraCare
    DoC HME DigiTop O2
    DoC Provox ActiValve
    DoC Provox ActiValve Lubricant
    DoC Provox Adhesive Remover
    DoC Provox Adhesive Strip
    DoC Provox Adhesives
    DoC Provox BasePlate Adaptor
    DoC Provox Brush
    DoC Provox Capsule
    DoC Provox Cleaning Towel
    DoC Provox Coming Home
    DoC Provox Dilator (REF 8341)
    DoC Provox Dilator 17 and 20 (REF 8342 & 8343)
    DoC Provox Electrolarynx
    DoC Provox Flush
    DoC Provox FreeHands FlexiVoice
    DoC Provox FreeHands HME
    DoC Provox FreeHands Support
    DoC Provox FreeHands Support Adhesive
    DoC Provox GuideWire
    DoC Provox HME Cap
    DoC Provox HME Cassette Adaptor
    DoC Provox LaryButton
    DoC Provox LaryClip
    DoC Provox LaryTube
    DoC Provox Life Adhesives
    DoC Provox Life BasePlate Adaptor
    DoC Provox Life Comfort Adhesive
    DoC Provox Life Experience Packs
    DoC Provox Life FreeHands HME
    DoC Provox Life HMEs
    DoC Provox Life LaryButton
    DoC Provox Life LaryTube
    DoC Provox Life Oxygen
    DoC Provox Life Shower
    DoC Provox Luna Adhesive
    DoC Provox Luna HME
    DoC Provox Luna Set
    DoC Provox Luna ShowerAid
    DoC Provox Measure
    DoC Provox Micron HME
    DoC Provox NID
    DoC Provox Plug, Vega Plug
    DoC Provox Protector
    DoC Provox ShowerAid
    DoC Provox Silicone Glue
    DoC Provox Skin Barrier
    DoC Provox Swab
    DoC Provox Tracheofix
    DoC Provox TubeBrush
    DoC Provox TubeHolder
    DoC Provox TwistLock
    DoC Provox Vega
    DoC Provox Vega Puncture Set
    DoC Provox Vega XtraSeal
    DoC Provox Wipes
    DoC Provox XtraFlange
    DoC Provox XtraHME
    DoC Provox2
    DoC Stoma Sizing Guide
    DoC TheraBite ActiveBand Kit
    DoC TheraBite Bite Pad
    DoC TheraBite Jaw Motion Rehab. System
    DoC TheraBite Range of Motion Scale
    DoC TrachPhone
    DoC Tracoe Aeris
    DoC Tracoe Care & Cleaning
    DoC Tracoe Comfort
    DoC Tracoe Dressings Care Compresses Unsterile
    DoC Tracoe Dressings Care Purofoam
    DoC Tracoe Experc Dilation Set
    DoC Tracoe Mini Extension Piece
    DoC Tracoe Neckbands
    DoC Tracoe Percutaneous Dilation
    DoC Tracoe Phon Assist I
    DoC Tracoe Silcosoft and Mini
    DoC Tracoe Smart
    DoC Tracoe Twist
    DoC Tracoe Twist Plus
    DoC Tracoe Vario
    Free Sales Certificate - Atos Medical Product range - Class II devices
    Free Sales Certificate - Atos Medical Product range - MDR Devices
    TechInfo Freevent Cloths Stoma Cover
    TechInfo Freevent Dressing Softfoam
    TechInfo Freevent Dressings
    TechInfo Freevent DualCare
    TechInfo Freevent Foam
    TechInfo Freevent Neckbands
    TechInfo Freevent O2 Adaptors
    TechInfo FreeVent TubeBrush
    TechInfo Freevent XtraCare
    TechInfo HME DigiTop O2
    TechInfo Provox ActiValve
    TechInfo Provox ActiValve Lubricant
    TechInfo Provox Adhesive Remover
    TechInfo Provox Adhesive Strip
    TechInfo Provox Adhesives
    TechInfo Provox BasePlate Adaptor
    TechInfo Provox Brush
    TechInfo Provox Capsule
    TechInfo Provox Cleaning Towel
    TechInfo Provox Coming Home
    TechInfo Provox Dilator (REF 8341)
    TechInfo Provox Dilator 17 and 20 (REF 8342 & 8343)
    TechInfo Provox Electrolarynx
    TechInfo Provox Flush
    TechInfo Provox FreeHands FlexiVoice
    TechInfo Provox FreeHands HME Cassette
    TechInfo Provox FreeHands Support
    TechInfo Provox FreeHands Support Adhesive
    TechInfo Provox GuideWire
    TechInfo Provox HME Cap
    TechInfo Provox HME Cassette Adaptor
    TechInfo Provox LaryButton
    TechInfo Provox LaryButton Sizer Kit
    TechInfo Provox LaryClip
    TechInfo Provox LaryTube
    TechInfo Provox LaryTube FR
    TechInfo Provox LaryTube Sizer Kit
    TechInfo Provox Life Adhesive
    TechInfo Provox Life BasePlate Adaptor
    TechInfo Provox Life Comfort Adhesive
    TechInfo Provox Life Experience Packs
    TechInfo Provox Life FH HME
    TechInfo Provox Life HME
    TechInfo Provox Life LaryButton
    TechInfo Provox Life LaryTube
    TechInfo Provox Life Oxygen
    TechInfo Provox Life Shower
    TechInfo Provox Luna Adhesive
    TechInfo Provox Luna HME
    TechInfo Provox Luna Set
    TechInfo Provox Luna ShowerAid
    TechInfo Provox Measure
    TechInfo Provox Micron HME
    TechInfo Provox NID
    TechInfo Provox Plug Vega Plug
    TechInfo Provox Protectors
    TechInfo Provox ShowerAid
    TechInfo Provox Silicone Glue
    TechInfo Provox Skin Barrier
    TechInfo Provox StabiliBase
    TechInfo Provox StabiliBase OptiDerm
    TechInfo Provox Swab
    TechInfo Provox Tracheofix
    TechInfo Provox TubeBrush
    TechInfo Provox TubeHolder
    TechInfo Provox TwistLock
    TechInfo Provox Vega
    TechInfo Provox Vega Puncture Set
    TechInfo Provox XtraFlange
    TechInfo Provox XtraHME
    TechInfo Provox2
    TechInfo Stoma Sizing Guide
    Techinfo TheraBite ActiveBand Kit
    TechInfo TheraBite Bite Pad
    TechInfo TheraBite Jaw Motion Rehab. System
    TechInfo TheraBite Range of Motion Scale
    TechInfo TrachPhone
    TechInfo Tracoe Aeris
    TechInfo Tracoe Comfort
    TechInfo Tracoe Comfort Plus
    TechInfo Tracoe Comfort XL
    TechInfo Tracoe CPM Sensitive
    TechInfo Tracoe Dressings Compress
    TechInfo Tracoe Dressings REF 958 & REF 959
    TechInfo Tracoe Dressings REF 969
    TechInfo Tracoe Experc Dilation Set
    TechInfo Tracoe Mini REF 350
    TechInfo Tracoe Mini REF 355
    TechInfo Tracoe Mini REF 356
    TechInfo Tracoe Neckbands
    TechInfo Tracoe Occlusion Cap
    TechInfo Tracoe Percutaneous Dilation REF 517
    TechInfo Tracoe Percutaneous Dilation REF 518
    TechInfo Tracoe Phon Assist I REF 650-T
    TechInfo Tracoe Phon Assist I REF 650-TO
    TechInfo Tracoe Phon Assist I REF 650-TO-5
    TechInfo Tracoe Phon Assist I REF 650-TO-C
    TechInfo Tracoe Phon Assist I REF 650-TO-C-5
    TechInfo Tracoe Silcosoft REF 360
    TechInfo Tracoe Silcosoft REF 361
    TechInfo Tracoe Silcosoft REF 362
    TechInfo Tracoe Silcosoft REF 363
    TechInfo Tracoe Silcosoft REF 370
    TechInfo Tracoe Silcosoft REF 371
    TechInfo Tracoe Silcosoft REF 372
    TechInfo Tracoe Silcosoft REF 373
    TechInfo Tracoe Smart
    TechInfo Tracoe Twist Plus REF 311
    TechInfo Tracoe Twist Plus REF 311-P
    TechInfo Tracoe Twist Plus REF 312
    TechInfo Tracoe Twist Plus REF 312-P
    TechInfo Tracoe Twist Plus REF 313
    TechInfo Tracoe Twist Plus REF 314
    TechInfo Tracoe Twist Plus REF 316
    TechInfo Tracoe Twist Plus REF 316-P
    TechInfo Tracoe Twist Plus REF 521
    TechInfo Tracoe Twist Plus REF 521-X
    TechInfo Tracoe Twist Plus REF 521-XXX
    TechInfo Tracoe Twist Plus REF 523
    TechInfo Tracoe Twist Plus REF 523-X
    TechInfo Tracoe Twist Plus REF 888-316
    TechInfo Tracoe Twist Plus REF 888-316-P
    TechInfo Tracoe Twist REF 301
    TechInfo Tracoe Twist REF 301-P
    TechInfo Tracoe Twist REF 302
    techInfo Tracoe Twist REF 302-P
    TechInfo Tracoe Twist REF 303
    TechInfo Tracoe Twist REF 304
    TechInfo Tracoe Twist REF 306
    TechInfo Tracoe Twist REF 306-P
    TechInfo Tracoe Twist REF 501
    TechInfo Tracoe Twist REF 501-X
    TechInfo Tracoe Twist REF 501-XXX
    TechInfo Tracoe Twist REF 506
    TechInfo Tracoe Twist REF 506-X
    TechInfo Tracoe Twist REF 888-306
    TechInfo Tracoe Twist REF 888-306-P
    TechInfo Tracoe Vario REF 450
    TechInfo Tracoe Vario REF 450-P
    TechInfo Tracoe Vario REF 451
    TechInfo Tracoe Vario REF 451-P
    TechInfo Tracoe Vario REF 455
    TechInfo Tracoe Vario REF 460
    TechInfo Tracoe Vario REF 460-P
    TechInfo Tracoe Vario REF 461
    TechInfo Tracoe Vario REF 461-P
    TechInfo Tracoe Vario REF 464
    TechInfo Tracoe Vario REF 470
    TechInfo Tracoe Vario REF 470-P
    TechInfo Tracoe Vario REF 471
    TechInfo Tracoe Vario REF 471-P
    Tracoe Declaration on Outer Packaging
    Tracoe Declaration on Primary Packaging
    Tracoe EC Certificate
    Tracoe EN ISO 13485:2016 Certificate
    Tracoe MDD extension letter
    Tracoe MDSAP ISO 13485:2016
    Tracoe Method of Disposal
    Tracoe MRI Safety Information
    Tracoe No Latex Declaration
    Tracoe Statement Compliance ISO 5366:2016

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Unsere Leitlinien

RegulatorischesQualitätssicherungIFUCookie-Hinweis

Unser Unternehmen

Das sind wirManagement-TeamVerhaltenskodexKarriereKontakt

Rechtliches

ImpressumNutzungsbedingungenAGBDatenschutzEinwilligungserklärung

Folgen Sie uns

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