BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Glucertain Blood Glucose Test Strips

    Reg #: 3007594734 · FEI: 3007594734 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CellEra, LLC
    Registration Number
    3007594734
    FEI Number
    3007594734
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1045 Reed Road, Unit C
    City
    Monroe
    State
    OH
    ZIP
    45050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112901

    Owner / Operator

    Firm Name
    CellEra, LLC
    Operator Number
    10029252
    Address
    1045 Reed Road, Unit C
    City
    Monroe
    State
    OH
    Postal Code
    45050
    Country
    US
    Correspondent
    Ken Heyl

    Products

    Device Name Product Code
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    Glucertain Blood Glucose Test Strips

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198