BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Varian Medical Systems Haan GmbH

    Reg #: 3016602874 · FEI: 3016602874 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    91
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    Varian Medical Systems Haan GmbH
    Registration Number
    3016602874
    FEI Number
    3016602874
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rheinische Strasse 2
    City
    Haan North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K151022

    Owner / Operator

    Firm Name
    Varian Medical Systems, Inc
    Operator Number
    2914292
    Address
    3100 Hansen Way, --
    City
    Palo Alto
    State
    CA
    Postal Code
    94304
    Country
    US

    US Agent

    Business Name
    Varian Medical Systems, Inc.
    Contact Name
    Ali Rezaei
    Address
    3100 Hansen Way
    City
    Palo Alto
    State
    CA
    ZIP
    94304
    Country
    US
    Email
    [email protected]
    Phone
    650 4246545

    Products

    Device Name Product Code
    System, Applicator, Radionuclide, Remote-Controlled JAQ
    System, Planning, Radiation Therapy Treatment MUJ
    Accelerator, Linear, Medical IYE
    Source, Brachytherapy, Radionuclide KXK

    Proprietary Names

    Intraluminal Applicator Set Mould Probe MR Safe Heyman Packing Applicator Set Guided Aarhus Applicator Set Vitesse v5 CT/ MR Tandem and Ovoid Set Heyman Packing Applicator Set (GM11004580) Surface Beacon Transponders Calypso Surface Beacon Transponders IDENTIFY 3 GammaMedplus Afterloader GammaMedplus Esophagus Bougie Set - GM11008880 VariSeed (v10) Surface Applicator Set GammaMedplus 3/24 Afterloader GammaMedplus 3/24 GammaMedplus iX Series High Dose Rate (HDR) / Pulsed Dose Rate (PDR) Afterloader system GammaMedplus iX GammaMedplus iX HDR / PDR GammaMedplus 3/24 iX HDR GammaMedplus 3/24 iX TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY Beacon Care Package - Soft Tissue (17G) Calypso Prostate Beacon Transponders Calypso Soft Tissue Beacon Transponders Calypso Permanent Beacon Transponders PLASTIC NEEDLE WITH MANDARIN 2 DIAMETER LENGTH 113MM Lead Stop Button Leak Stop Channel Marker Set, 25-30 Leak Stop Channel Marker Set, 13-24 Leak Stop Channel Marker Set, 01-12 VARIAN INTERSTITIAL TITANIUM NEEDLES Identify (5) Advanced Breast Template System Titaniuim Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve Cervical Sleeves Universal Endometrial Applicator Set Shielded Applicator Set Reusable Transfer Guide Tubes Universal Sterilization Box Mould Applicator Set APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER Plastic needle 2 mm diameter Kelowna GYN and Crook Prostate Templates GammaMedplus Source Guide Tubes VARIAN NASOPHARYNX APPLICATOR The Flexible Fixation Device for Gynecological Applicators 3D Interstitial Ring Applicator Set 90 degree Ring Applicator Set 60 degree Ring Applicator Set 90 degree Ring Applicator Set 45 degree Eclipse Treatment Planning System Standard Catheter Set Universal Titanium Cervix Probe Set, even lengths Universal Titanium Cervix Probe Set, odd lengths Intracavitary/Interstitial System Titanium Flexible Geometry FSD Applicator Set (GM11013400) Kelowna GYN Template Crook Prostate Template Surface Applicator Set with Leipzig-style Cone Universal Segmented Cylinder Applicator Set Universal Cervix Probe Set, even lengths Universal Stump Applicator Set Universal Cervix Probe Set, odd lengths Intraluminal Polymeric Products VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS Flexible Interstitial Implant Tube Set Aarhus Applicator Set Interstitial Needles Identify (4) GammaMed 12i(t) Source Wire Assembly GammaMedplus Source Wire Assembly GammaMedplus 232 Source Assembly GammaMed 12i(t) Source Wire GammaMed 212 Source Assembly Catheter Surface Flap Applicator Set BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device Universal Cylinder Applicator Family VariSource iX Series Afterloader VariSource iX HDR Afterloader VariSource iX VariSource iX(t) VariSource iX Series VariSource iX Afterloader VariSource iX(t) Afterloader VariSource iX(t) HDR Afterloader VariSource iX Series Afterloader Systems Anchored Beacon Transponder MAASTRO Rectal Applicator Set Vitesse

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198