BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CERTA DOSE

    Reg #: 3014759854 · FEI: 3014759854 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    CERTA DOSE
    Registration Number
    3014759854
    FEI Number
    3014759854
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2590 Welton Street, #200
    City
    Denver
    State
    CO
    ZIP
    80205
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160589

    Owner / Operator

    Firm Name
    CD Acquisitions, LLC (Certa Dose)
    Operator Number
    10058186
    Address
    2590 Welton Street, #200
    City
    Denver
    State
    CO
    Postal Code
    80205
    Country
    US
    Correspondent
    Caleb Hernandez

    Products

    Device Name Product Code
    Epinephrine Syringe PQX
    Adaptor, Holder, Syringe IQG

    Proprietary Names

    Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe Certa Dose PALS Syringe Holder Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility