BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DRAEGERWERK AG & CO. KGAA

    Reg #: 3001104093 · FEI: 3023530182 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    66
    Establishment Types
    4
    Classifications
    16

    Registration Details

    Registration Name
    DRAEGERWERK AG & CO. KGAA
    Registration Number
    3001104093
    FEI Number
    3023530182
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    REVALSTRASSE 1
    City
    LUEBECK Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K081743

    Owner / Operator

    Firm Name
    Draegerwerk AG & Co. KGaA
    Operator Number
    8010046
    Address
    53-55 MOISLINGER ALLEE, --
    City
    LUEBECK
    State
    DE-NOTA
    Postal Code
    23542
    Country
    DE

    US Agent

    Business Name
    DRAEGER MEDICAL SYSTEMS, INC.
    Contact Name
    Melissa Gray
    Address
    6 TECH DRIVE
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US
    Email
    [email protected]
    Phone
    978 4473613

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK
    Gas-Machine, Anesthesia BSZ
    Incubator, Neonatal FMZ
    Warmer, Infant Radiant FMT
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Unit, Neonatal Phototherapy LBI
    Filter, Bacterial, Breathing-Circuit CAH
    Lamp, Surgical FTD
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Transducer, Gas Flow BXP
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Medical Device Data System OUG
    System, Network And Communication, Physiological Monitors MSX
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX

    Proprietary Names

    NovaStar ClassicStar Evita V800 Evita V600 Babylog 8000 Anesthesia Workstation Perseus A500 Perseus A500 Atlan Apollo Oxylog 1000 Babylog VN800 Babylog VN600 Babyleo TN500 VarioVac Oxylog 3000 and Accessories Photo Therapie 4000 PT 4000 Carina Fabius MRI VentView Filter SafeStar Plus Filter/HME TwinStar Plus Filter CareStar Plus Polaris 600 Polaris Atlan A100 XL Atlan A100 Atlan A350 XL Atlan A350 Polaris 100/200 Oxylog 3000 Plus with accessories Evita V600 Evita V800 Babylog 8000 plus Neonatal Flow Sensor ISO15 Neonatal Flow Sensor Insert Neonatal flow sensor Y-piece IBP transducer adapter cable, Codan/DPT, 0.3m IBP transducer adapter cable, Draeger 7-pin, 0.3m IBP transducer adapter cable, Argon/BD/Ohmeda, 2m IBP transducer adapter cable, Baxter/Edwards, 2m IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m IBP transducer adapter cable, Baxter/Edwards, 0.3m IBP transducer adapter cable, Draeger 7-pin, 2m IBP transducer adapter cable, Draeger 10-pin, 0.3m IBP transducer adapter cable, Utah Medical, 2m IBP transducer adapter cable, Draeger 10-pin, 2m IBP transducer adapter cable, Utah Medical, 0.3m IBP transducer adapter cable, Codan/Xtrans, 0.3m IBP transd. adapter cable, Abbott/Medex, Smiths/TranStar, 0.3m IBP transducer adapter cable, Codan/DPT, 2m IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m Savina Spirolog Flow Sensor SpiroLife Infinity ID Flow Sensor IACS WS CriticalCare w V500 HME HumidStar Connectivity Converter CC300 Caleo Infinity C700 for IT CO2 Mainstream Sensor INFINITY MONITORS WITH SCIO MODIFICATIONS Evita 4 Babytherm 8004, 8010 Savina 300 - Classic, Select Savina 300

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device