BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ERBE Elektromedizin GmbH

    Reg #: 3009762450 · FEI: 3009762450 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ERBE Elektromedizin GmbH
    Registration Number
    3009762450
    FEI Number
    3009762450
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rudolf-Diesel-Str. 29
    City
    Rangendingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K243120

    Owner / Operator

    Firm Name
    ERBE ELEKTROMEDIZIN GMBH
    Operator Number
    8010173
    Address
    WALDHOERNLESTRASSE 17, --
    City
    TUEBINGEN
    State
    DE-NOTA
    Postal Code
    72072
    Country
    DE

    US Agent

    Business Name
    ERBE USA, INC.
    Contact Name
    John Tartal
    Address
    2225 Northwest Pkwy SE
    City
    Marietta
    State
    GA
    ZIP
    30067
    Country
    US
    Email
    [email protected]
    Phone
    770 9554400 ext. 133

    Products

    Device Name Product Code
    Lavage, Jet FQH
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Unit, Cryosurgical, Accessories GEH
    Electrode, Electrosurgical JOS

    Proprietary Names

    HybridAPC probe ERBEJET® 2 System ERBE Hybrid Knife FiAPC Plus ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe ERBECRYO® 2 Cart ERBECRYO® 2 1-pedal footswitch ERBECRYO® 2, Cryosurgical unit Flexible gas hose Gas bottle adapter Exhaust gas hose Flexible Cryoprobe Extension cable Switching valve with 2 adapters MOVIVA Hybrid Ablation Probe ERBEJET 2 System ERBEJET 2 two pedal footswitch HybridTherm System: Electrosurgical Unit VIO 3, Cryosurgical Unit ERBECRYO 2, HybridTherm probes, accessories Erbe APCapplicators HybridAPC Probe ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe FiAPC plus probes HYBRIDknife® flex

    Establishment Types

    Manufacture Medical Device