BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    BIOTRONIK SE & CO. KG

    Reg #: 9610139 · FEI: 3002806500 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    163
    Establishment Types
    5
    Classifications
    26

    Registration Details

    Registration Name
    BIOTRONIK SE & CO. KG
    Registration Number
    9610139
    FEI Number
    3002806500
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    WOERMANNKEHRE 1
    City
    BERLIN
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K151409
    PMA Number
    P210037

    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
    Catheter, Percutaneous DQY
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Stylet, Catheter DRB
    Pacemaker Lead Adaptor DTD
    Wire, Guide, Catheter DQX
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Magnet, Test, Pacemaker DTG
    Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) MXD
    Pulse Generator, Permanent, Implantable NVZ
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Permanent Pacemaker Electrode DTB
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Pulse Generator, External Pacemaker, Dual Chamber OVJ
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Programmer, Pacemaker KRG
    Implantable Pacemaker Pulse-Generator DXY
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX
    Defibrillator, Implantable, Dual-Chamber MRM
    Pulse-Generator, Pacemaker, External DTE
    Analyzer, Pacemaker Generator Function DTC
    Permanent Defibrillator Electrodes NVY
    Tester, Pacemaker Electrode Function DTA

    Proprietary Names

    Selectra IC Resilience Percutaneous Lead Prospera Spinal Cord Stimulation (SCS) System HomeStream Remote Management TrueLock Embrace One S 60-S S 60-J S 60-K S 53-K S 45-S S 45-J S 53-J S 45-K S 53-JL S 60-F S 65-A S 45-F S 65-E S 85-G OTW S 45-JL S 85-K OTW S 53-F S 75-K S 60-C S 65-C S 65-K S 75-G OTW S 75-K OTW S 53-S S 75-C A1-CS-SB Selectra Accessory Kit MPK-4-R MPK-10-R BIOTRONIK test magnet BioMonitor 2-AF BioMonitor 2-S FIT - Fast Insert Tool 1 + 2, Set Remote Assistant Patient App Version 2.9 BIOMONITOR III BIOMONITOR IIIm Selectra slitter tool Selectra Selectra IC – 90 – 69 Selectra Hook – 55 Selectra 3D-40-39 Selectra Extended Hook – 55 Selectra Amplatz 6 – 45 Selectra Multipurpose Hook – 45 Selectra Straight – 55 Selectra IC – 50 – 59 Selectra 3D-55-32 Selectra 3D-55-42 Selectra Extended Hook – 45 Selectra Right – 55 Selectra Amplatz 6 – 55 Selectra Slitter Tool Selectra 3D-40-42 Selectra MPEP – 55 Selectra IC – 90 – 59 Selectra MPEP – 45 Selectra Right – 45 Selectra Straight – 45 Selectra BIO2 – 45 Selectra BIO2 – 55 Selectra 3D-65-32 Selectra 3D-40-32 Selectra 3D-65-39 Selectra Multipurpose Hook – 55 Selectra IC – 50 – 69 Selectra 3D-65-42 Selectra Hook – 45 Selectra 3D-55-39 BK-IS BK-A BK-B Model 6653 EDP Model 3150 Renamic P-KIT Estella Model 3145 Dextrus Reliaty Reocor Model 6652 Model 3171 Setrox S Effecta Model 6646 Evia ICS 3000 Selox Model 3175 Tilda Solia T 53 Solia S 60 Solia CSP S 53 Solia JT 45 Solia CSP S 60 Solia S 45 Solia S 53 Solia T 60 Solia JT 53 VisionWire PSW 1503.U PSW 1502.U Etrinsa HF-T Eluna HF-T Edora Evity Enitra Sentus OTW QP L/S Stratos CardioMessenger Corox Celerity LV-KIT Evia HF(-T) Home Monitoring Iforia Iperia Itrevia Inventra PSW 1507.U PSW 1506.U BS IS4 Ilivia Intica Acticor family CardioMessenger Smart 4G Acticor Sky Lumax Ilesto Selectra Lead Introducer System Patient App Version 2.2 Patient App 2.5 Patient App 2.4.1 Patient App 2.7 Biomonitor BK-N ERA 300 PK-141 Patient Cable BIOMONITOR IV PA-10 DH DF4 BK-IS4/DF4 IS4/DF4 Adapter Protego PA-11 Plexa Plexa ProMRI S DX Plexa ProMRI 60 cm D2-KIT Linox D-KIT Kainox VCS Vigila Volta Pamira Linoxsmart Remote Assistant III PSW 1301.U

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device