BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Home Monitoring

    Reg #: 9610139 · FEI: 3002806500 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    88
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    BIOTRONIK SE & CO. KG
    Registration Number
    9610139
    FEI Number
    3002806500
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    WOERMANNKEHRE 1
    City
    BERLIN
    Country
    DE

    Regulatory Submissions

    PMA Number
    P950037

    Owner / Operator

    Firm Name
    BIOTRONIK SE & CO. KG
    Operator Number
    9018331
    Address
    6024 Jean Road
    City
    Lake Oswego
    State
    OR
    Postal Code
    97035
    Country
    US

    US Agent

    Business Name
    BIOTRONIK, Inc.
    Contact Name
    Jon Brumbaugh
    Address
    6024 Jean Rd
    City
    Lake Grove
    State
    OR
    ZIP
    97035
    Country
    US
    Email
    [email protected]
    Phone
    503 9707014

    Products

    Device Name Product Code
    Pulse Generator, Permanent, Implantable NVZ
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Permanent Pacemaker Electrode DTB
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Pulse Generator, External Pacemaker, Dual Chamber OVJ
    Programmer, Pacemaker KRG
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Implantable Pacemaker Pulse-Generator DXY

    Proprietary Names

    Home Monitoring Solox Entovis Probetection Safio S EFH Etrinsa Eluna PSW 1506.u/1 PSW 1507.U PSW 1506.U PSW 1702.U Solia Edora Evity EFH-6F-W HMSC Version 3.39 HMSC Version 3.40 PSW 1703.U HMSC Version 3.41 Solia T/JT PSW 1704.U PSW 1804.U HMSC Version 3.44 HMSC Version 3.45 PSW 1901.U PSW 1904.U HMSC Version 3.47 PSW 1801.U HMSC Version 3.43 HMSC Version 3.48 HMSC Version 3.42 NEO 2004.U PSW 2100.U NEO 2100.U PSW 2100.U/1 PK-222-L ECG Cable NEO 2201.U/1 Renamic Neo Programmer PK-155-B HMSC Version 3.54 Reliaty PSW 2201.U/1 EDP Setrox S Dextrus Effecta Selox HMSC Version 3.53 Model 6653 P-KIT Tilda ICS 3000 PSW 2202.U Model 3145 Renamic SLX Solvia NEO 2303.U PSW 2301.U PSW 2204.U Model 3175 Ecuro Model 6652 PSW 2401.U Model 3150 HMSC Version 3.60 NEO 2204.U NEO 2401.U/1 Renamic Neo NEOexpress Evia Model 3171 HMSC Version 3.57 NEO 2302.U Amvia NEO 2401.U Estella CardioMessenger Reocor Model 6646 HMSC Version 3.62 HMSC Version 3.58 NEO 2301.U NEO 2202.U PSW 2303.U HMSC 3.55 PSW 2302.U HMSC Version 3.63

    Establishment Types

    Manufacture Medical Device