BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Fiber Optic for PLA Long green

    Reg #: 3009039068 · FEI: 3009039068 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    33
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HA2 MEDIZINTECHNIK GMBH
    Registration Number
    3009039068
    FEI Number
    3009039068
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Am Bahndamm 11
    City
    Halberstadt Saxony-Anhalt
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K140470

    Owner / Operator

    Firm Name
    HA2 Medizintechnik GmbH
    Operator Number
    10042677
    Address
    Am Bahndamm 11
    City
    Halberstadt
    State
    Saxony-Anhalt
    Postal Code
    38820
    Country
    DE
    Correspondent
    Regina Koelzsch

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Fiber Optic for PLA Long green Corona 360 Radial Fiber 600?m Fiber Optic for MRI red Laser Surgery Fiber - Radial Emission 600?m Stopper Laser Surgery Fiber - Radial Emission 400?m Stopper Radial Emission Fiber 400?m Laser Surgery Fiber – Radial Emission 400?m Vein Fiber Optic for PLA Short yellow Laser Surgery Fiber – Chirurgie Bare Fiber 320?m Fiber Optic for PLA Short red Laser Surgery Fiber – Dental Bare Fiber 200?m Corona 360 Fiber 600?m Fiber Optic for PLA Long red Fiber Optic for PLA Long blue Laser Surgery Fiber - Radial Emission 600?m Vein Fiber Optic for MRI yellow Fiber Optic for PLA Long yellow Laser Surgery Fiber - Radial Emission 400?m Laser Surgery Fiber 600?m Laser Surgery Fiber - DiLA’S® Laser Thyroid Probe Laser Surgery Fiber - DiLA’S® Laser Hemorrhoid Probe Laser Surgery Fiber - DiLA’S® Laser Radial Venous Probe Fiber Optic for PLA Short blue Laser Surgery Fiber - DiLA’S® Laser Fistula Probe Dental Surgery Fiber 320?m General Surgery Fiber 400um Laser Surgery Fiber 600?m 2.6m Laser Surgery Fiber - Dental Bare Fiber 320?m Fiber Optic for MRI green Fiber Optic for MRI blue Fiber Optic for PLA Short green Laser Surgery Fiber - DiLA’S® Laser PLDD Probe Laser Surgery Fiber - DiLA’S® Laser Slenderflex Venous Probe

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)