BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZyMot ICSI Sperm Separation Device

    Reg #: 3014527900 · FEI: 3014527900 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DxNow Inc.
    Registration Number
    3014527900
    FEI Number
    3014527900
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    401 Professional Drive, Suite 130
    City
    Gaithersburg
    State
    MD
    ZIP
    20879
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173075

    Owner / Operator

    Firm Name
    DxNow, Inc.
    Operator Number
    10057557
    Address
    401 Professional Drive, Suite 130
    City
    Gaithersburg
    State
    MD
    Postal Code
    20879
    Country
    US
    Correspondent
    Mauro Castro

    Products

    Device Name Product Code
    Labware, Assisted Reproduction MQK

    Proprietary Names

    ZyMot ICSI Sperm Separation Device ZyMot Multi Sperm Separation Device

    Establishment Types

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