BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    MultiPulse HoPLUS

    Reg #: 3009039068 · FEI: 3009039068 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    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
    K231876

    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
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    MultiPulse HoPLUS

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)