BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Bladder EpiCheck

    Reg #: 3012885391 · FEI: 3012885391 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NUCLEIX LTD.
    Registration Number
    3012885391
    FEI Number
    3012885391
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 Pekeris Street
    City
    Rehovot Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K203245

    Owner / Operator

    Firm Name
    Nucleix Ltd.
    Operator Number
    10088381
    Address
    3 Pekeris Street
    City
    Rehovot
    State
    Central
    Postal Code
    7670203
    Country
    IL
    Correspondent
    Anna Miller

    US Agent

    Business Name
    Nucleix Inc.
    Contact Name
    Chris Hibbered
    Address
    10675 Sorrento Valley Road, Ste 250
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US
    Email
    [email protected]
    Phone
    858 2482137

    Products

    Device Name Product Code
    System, Test, Tumor Marker, Monitoring, Bladder MMW

    Proprietary Names

    Bladder EpiCheck

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device