BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORIGIO Sperm Wash 84051010

    Reg #: 1216677 · FEI: 1216677 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    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
    K153267

    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

    ORIGIO Sperm Wash 84051010 ORIGIO Gradient 100 84004125 84000060A, 84002060A, 84004125A, 84010060A, 84021210A, 84022010A, 84022060A, 84050060A, 84051010A, 84055060A 84000060F, 84002060F, 84004125F, 84010060F, 84021210F, 84022010F, 84022060F, 84050060F, 84051010F, 84055060F ORIGIO Gradient 80 ORIGIO Gradient 90 ORIGIO Gradient 40 ORIGIO Gradient 100 Sperm Wash ORIGIO Gradient 40/80 ORIGIO Gradient 40/80 84021210 ORIGIO Gradient 40/80 84022010 ORIGIO Gradient 40/80 84022060 ORIGIO Gradient 100 84002060 ORIGIO Gradient 100 84000060 ORIGIO Sperm Wash 84050060 84000060D, 84002060D, 84004125D, 84010060D, 84021210D, 84022010D, 84022060D, 84050060D, 84051010D, 84055060D ORIGIO Sperm Wash 84055060 ORIGIO Sperm Wash 8405 ORIGIO Gradient 90 84010060

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device