BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Jaeger Medical GmbH

    Reg #: 9615102 · FEI: 1000271197 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    70
    Establishment Types
    3
    Classifications
    30

    Registration Details

    Registration Name
    Jaeger Medical GmbH
    Registration Number
    9615102
    FEI Number
    1000271197
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LEIBNIZSTRASSE 7
    City
    HOECHBERG Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K031102

    Owner / Operator

    Firm Name
    Jaeger Medical GmbH
    Operator Number
    10092652
    Address
    Leibnizstrasse 7
    City
    Hoechberg
    State
    Bavaria
    Postal Code
    97204
    Country
    DE
    Correspondent
    Jared Cardon

    US Agent

    Business Name
    Jaeger Medical America
    Contact Name
    Cally Kothmann
    Address
    14050 Rebecca St
    City
    Moreno Valley
    State
    CA
    ZIP
    92553
    Country
    US
    Email
    [email protected]
    Phone
    714 6858094

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG
    Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase CCJ
    Medical Device Data System OUG
    Plethysmograph, Volume JEH
    Calculator, Predicted Values, Pulmonary Function BTY
    Calculator, Pulmonary Function Data BZC
    Electrocardiograph DPS
    Mouthpiece, Breathing BYP
    Oximeter DQA
    Ventilatory Effort Recorder MNR
    Electromyograph, Diagnostic IKN
    Monitor, St Segment MLC
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Filter, Bacterial, Breathing-Circuit CAH
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Meter, Peak Flow, Spirometry BZH
    Regulator, Pressure, Gas Cylinder CAN
    Plethysmograph, Pressure CCM
    Valve, Prosthesis ISP
    Exerciser, Measuring ISD
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Computer, Diagnostic, Programmable DQK
    Computer, Oxygen-Uptake BZL
    Standard Polysomnograph With Electroencephalograph OLV
    Transducer, Gas Flow BXP
    Clip, Nose BXJ
    Analyzer, Gas, Helium, Gaseous-Phase BSE
    Calibrator, Volume, Gas BXW

    Proprietary Names

    MicroLab SpiroUSB Smokecheck MicroCO Sentry Connect Interface (MDDS) MasterScreen Diffusion MasterScreen Body SpiroSoft Vyntus ONE VIP Pulmonary Function System Disposable Mouthpiece, Flex V-892894 Disposable Mouthpiece, plastic 892103 Disposable Mouthpiece, plastic V-892896 Disposable Mouthpiece, Flex V-892893 Disposable Mouthpiece, Flex V-892897 MasterScreen Pneumo SentrySuite Product Line 2.7 MicroLoop Pulmolife Oxycon Mobile ApnoeScreen Pro MicroGP / MicroDL NeuroScreen Oxycon Pro MicroRPM MicroGard I Microgard Microbial Filter N2O Test MS CPX partially mobile SentrySuite Product Line 2.3 MicroPeak CO Test Gas Cylinder 706960 Pressure Regulator Static and Dynamic Compliance for Vmax APS Pro Vyntus BODY Vyntus CPX / Vyntus ECG MS Paed - Baby Body Ergotest 40 & 45 Vyntus SPIRO Unerversal Ergotest Micro Spirometer MasterScreen PFT Body MasterScreen CPX & Oxycon CPX Vyntus / SentrySuite Product Line Vyntus ECG O2 Test CO2 Test Micro I Diagnostic Spirometer Sentry WEB Smartinterp Ergo-Pneumotest Somno Star & Series Sleep System MS Paed - Baby Body option Squeeze V-707377 USS Module Vyntus WALK Vyntus CPX, Vyntus / SentrySuite Product Line MasterScreen IOS (JLAB 5.x) Nose clip reusable V-892895 Nose clip single patient use V-892900 Nose clip pad single patient use 892121 Micro Diary Spirometer SleepScreen HE TEST MicroGard II Filter Kit MicroGard II Filter Calibration Syringe V-720254-13 JQM Syringe V-720000-13 SentrySuite Product Line 2.5 Vmax 229 Series

    Establishment Types

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