BEUDAMED
    FDA Registration Active 🇺🇸 United States

    83030010F, 83030060F, 83040010F, 83040060F

    Reg #: 1216677 · FEI: 1216677 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    22
    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
    K133912

    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

    83030010F, 83030060F, 83040010F, 83040060F 83010010F, 83010060F, 83020010F, 83020060F 83030010A, 83030060A, 83040010A, 83040060A Sequential Fert with phenol red 83020010 Sequential Cleav w/o phenol red 83030060 Sequential Fert w/o phenol red 8301 83030010D, 83030060D, 83040010D, 83040060D Sequential Cleav 83030010, 83030060, 83040010, 83040060 ORIGIO Sequential Cleav ORIGIO Sequential Fert Sequential Cleav with phenol red 83040010 Sequential Cleav with phenol red 83040060 Sequential Fert w/o phenol red 83010060 Sequential Cleav w/o phenol red 8303 Sequential Cleav with phenol red 8304 Sequential Cleav w/o phenol red 83030010 Sequential Fert w/o phenol red 83010010 83010010D, 83010060D, 83020010D, 83020060D 83010010A, 83010060A, 83020010A, 83020060A Sequential Fert 83010010, 83010060, 83020010, 83020060 Sequential Fert with phenol red 83020060 Sequential Fert with phenol red 8302

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device