BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ERBE ELEKTROMEDIZIN GMBH

    Reg #: 9610614 · FEI: 3002806920 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    49
    Establishment Types
    3
    Classifications
    9

    Registration Details

    Registration Name
    ERBE ELEKTROMEDIZIN GMBH
    Registration Number
    9610614
    FEI Number
    3002806920
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    WALDHOERNLESTRASSE 17
    City
    TUEBINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K972269

    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.
    City
    MARIETTA
    State
    GA
    ZIP
    30067
    Country
    US
    Email
    [email protected]
    Phone
    770 9554400 ext. 133

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Endoscopic Irrigation/Suction System OCX
    Electrode, Electrosurgical JOS
    Lavage, Jet FQH
    Unit, Cryosurgical, Accessories GEH
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Resectoscope, Working Element FDC
    Electrode, Electrosurgical, Active, Urological FAS
    Resectoscope FJL

    Proprietary Names

    NESSY/Single Return Electrodes ERBE VIO 300 D with Accessories APC Applicators ERBEFLO 2 Disposable Tubing System VIO® 3 with Accessories Return Electrode Connecting Cables ERBE EIP 2 FiAPC plus probes ERBEJET® 2 System APC 2 and Accessories HybridTherm System: Electrosurgical Unit VIO 3, Cryosurgical Unit ERBECRYO 2, HybridTherm probes, accessories ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe NESSY Omega Return Electrodes FiAPC Plus APCapplicators APC 3 Argon Plasma Coagulation Unit VIO® Cart HybridAPC probe APC Pressure Reducer w/Sensor FiAPC® probes MOVIVA Hybrid Ablation Probe ERBEJET 2 System ERBEJET 2 two pedal footswitch ERBE ESU Model VIO dV with accessories VIO 200 S ERBE VIO ESU APC Integrated Filter Probes FiAPC probe w/filter 2200A, O.D. 3.6mm/10.8Fr, L. 2.2m/7.2ft Erbe APCapplicators ERBE Hybrid Knife HybridAPC Probe ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe Accessories for ERBE ESUs ERBE VIO 100 C ERBECRYO 2 Cryosurgical Unit and Accessories 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 ERBE VIO dV HYBRIDknife® flex APC Probes Erbe ESU Model VIO® 3n with Accessories HF Bipolar Connecting Cable

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)