BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vyntus ONE

    Reg #: 3033959233 · FEI: 3033959233 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Jaeger Medical America Inc.
    Registration Number
    3033959233
    FEI Number
    3033959233
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    14050 Rebecca St Bldg 4
    City
    Moreno Valley
    State
    CA
    ZIP
    92553
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181524

    Owner / Operator

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

    Products

    Device Name Product Code
    Electrocardiograph DPS
    Calculator, Pulmonary Function Data BZC

    Proprietary Names

    Vyntus ONE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device