BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SynVitro® Flush w/o Heparin 15840125

    Reg #: 1216677 · FEI: 1216677 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COOPERSURGICAL, INC.
    Registration Number
    1216677
    FEI Number
    1216677
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    95 CORPORATE DRIVE
    City
    Trumbull
    State
    CT
    ZIP
    06611
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003163

    Owner / Operator

    Firm Name
    COOPERSURGICAL, INC.
    Operator Number
    9002384
    Address
    95 CORPORATE DR., --
    City
    Trumbull
    State
    CT
    Postal Code
    06611
    Country
    US
    Correspondent
    Mauro Castro

    Products

    Device Name Product Code
    Media, Reproductive MQL

    Proprietary Names

    SynVitro® Flush w/o Heparin 15840125 15840125A 15840125F 15840125D SynVitro® Flush without Heparin 15840125 SynVitro® Flush 15840125

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device