BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OPTIK2-11

    Reg #: 1216677 · FEI: 1216677 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    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
    K140754

    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
    Colposcope (And Colpomicroscope) HEX

    Proprietary Names

    OPTIK2-11 OPTIK1-00 OPTIK2-05-002 OPTIK2-04 OPTIK1-02 OPTIK2-03-002 OPTIK2-05 OPTIK1-01 OPTIK2-03 Leisegang Colposcopes OPTIK2-04-002 OPTIK1-03

    Establishment Types

    Repack or Relabel Medical Device