BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CeQur Simplicity Inserter

    Reg #: 1000165286 · FEI: 1000165286 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Biomerics Winston-Salem
    Registration Number
    1000165286
    FEI Number
    1000165286
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2701 Boulder Park Ct
    City
    Winston Salem
    State
    NC
    ZIP
    27101
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163357

    Owner / Operator

    Firm Name
    Biomerics Winston-Salem
    Operator Number
    9050621
    Address
    2701 BOULDER PARK COURT, --
    City
    Winston Salem
    State
    NC
    Postal Code
    27101
    Country
    US
    Correspondent
    Greicy Barahona

    Products

    Device Name Product Code
    Pump, Infusion, Insulin Bolus OPP

    Proprietary Names

    CeQur Simplicity Inserter CeQur Simplicity Starter Kit CeQur Simplicity Patch Replacement Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)