BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Eberle GmbH & Co. KG

    Reg #: 3005820796 · FEI: 3005820796 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    56
    Establishment Types
    2
    Classifications
    7

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    Registration Details

    Registration Name
    Eberle GmbH & Co. KG
    Registration Number
    3005820796
    FEI Number
    3005820796
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    GLASBRONNENSTRASSE 6
    City
    WURMBERG Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K061134

    Owner / Operator

    Firm Name
    EFS-EBERLE FEINWERKTECHN. SYSTEME GMBH & CO. KG
    Operator Number
    9086231
    Address
    GLASBRONNENSTRASSE 6, --
    City
    WURMBERG
    State
    DE-NOTA
    Postal Code
    D-75449
    Country
    DE

    US Agent

    Business Name
    INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
    Contact Name
    GERALDGOIGITZER Goigitzer
    Address
    320 International Pkwy
    City
    Sunrise
    State
    FL
    ZIP
    33325
    Country
    US
    Email
    [email protected]
    Phone
    954 2178780 ext. 0

    Products

    Device Name Product Code
    Hearing Aid, Bone Conduction LXB
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Accessories, Cleaning Brushes, For Endoscope MNL
    Laryngostroboscope EQL
    Bur, Ear, Nose And Throat EQJ
    Arthroscope HRX
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    OTOMAG BONE CONDUCATION HEARING SYSTEM ENT/NEURO/OMF System and Accessory (41305RN) ENT/NEURO/OMF System and Accessory (41305D) ENT/NEURO/OMF System and Accessory (41301KSA) ENT/NEURO/OMF System and Accessory (41304KKF) ENT/NEURO/OMF System and Accessory (41301GN) ENT/NEURO/OMF System and Accessory (41305DW) ENT/NEURO/OMF System and Accessory (41201KK) ENT/NEURO/OMF System and Accessory (41304KKB) ENT/NEURO/OMF System and Accessory (41303KNF) ENT/NEURO/OMF System and Accessory (41301LN) ENT/NEURO/OMF System and Accessory (41304W) ENT/NEURO/OMF System and Accessory (41303GNF) ENT/NEURO/OMF System and Accessory (41303KNB) ENT/NEURO/OMF System and Accessory (41201SN) ENT/NEURO/OMF System and Accessory (41303KKFA) ENT/NEURO/OMF System and Accessory (41201GN) ENT/NEURO/OMF System and Accessory (41201LSA) ENT/NEURO/OMF System and Accessory (41303KKF) ENT/NEURO/OMF System and Accessory (41301KKSA) ENT/NEURO/OMF System and Accessory (41303KKB) ENT/NEURO/OMF System and Accessory (41201KN) ENT/NEURO/OMF System and Accessory (41301SN) ENT/NEURO/OMF System and Accessory (41303KKBA) ENT/NEURO/OMF System and Accessory (41303GNB) ENT/NEURO/OMF System and Accessory (41302KN) ENT/NEURO/OMF System and Accessory (41305DN) ENT/NEURO/OMF System and Accessory (41301LX) ENT/NEURO/OMF System and Accessory (41304KKFA) ENT/NEURO/OMF System and Accessory (41201LN) ENT/NEURO/OMF System and Accessory (41201KKSA) ENT/NEURO/OMF System and Accessory (41301KN) ENT/NEURO/OMF System and Accessory (41301LSA) ENT/NEURO/OMF System and Accessory (41301KK) ENT/NEURO/OMF System and Accessory (41201KKSB) ENT/NEURO/OMF System and Accessory (41201KSA) ENT/NEURO/OMF System and Accessory (40711040) ENT/NEURO/OMF System and Accessory (41303WN) ENT/NEURO/OMF System and Accessory (41303DT) ENT/NEURO/OMF System and Accessory (41304KKBA) ENT/NEURO/OMF System and Accessory (41301LXA) ENT/NEURO/OMF System and Accessory (41301KKSB) Cleaning Brushes and kits (41200RA) Cleaning Brushes and kits (41250RA) KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES Tamberger-Sachase Intranasal Drill (41335DT) Tamberger-Sachase Intranasal Drill (41335DS) Tamberger-Sachase Intranasal Drill (41335W) Tamberger-Sachase Intranasal Drill (41335DW) Tamberger-Sachase Intranasal Drill (41335RN) EBERLE SHAVER SYSTEM Eberle Shaver system Accessories HEMPFLING Dilation Set (28140W) OTOMAG BONE CONDUCTION HEARING SYSTEM OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) PBT Piloted Bone Trephine

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device