BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    LEISEGANG FEINMECHANIK-OPTIK GMBH

    Reg #: 9611604 · FEI: 3002807462 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    LEISEGANG FEINMECHANIK-OPTIK GMBH
    Registration Number
    9611604
    FEI Number
    3002807462
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LEIBNIZSTRASSE 32
    City
    BERLIN
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K140754

    Owner / Operator

    Firm Name
    COOPERSURGICAL, INC.
    Operator Number
    9002384
    Address
    95 CORPORATE DRIVE, --
    City
    Trumbull
    State
    CT
    Postal Code
    06611
    Country
    US
    Correspondent
    Brian Szeremeta

    US Agent

    Business Name
    COOPER SURGICAL
    Contact Name
    Brian Szeremeta
    Address
    95 Corporate Drive, TRUMBULL, CONNECTICUT, 06611, UNITED STATES
    City
    Trumbull
    State
    CT
    ZIP
    06611
    Country
    US
    Email
    [email protected]
    Phone
    203 6015200

    Products

    Device Name Product Code
    Colposcope (And Colpomicroscope) HEX

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device