BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    TUTTNAUER LTD.

    Reg #: 8030087 · FEI: 3005343391 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    TUTTNAUER LTD.
    Registration Number
    8030087
    FEI Number
    3005343391
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    HAR-TUV INDUSTRIAL ZONE, BOX 170
    City
    BEIT SHEMESH Jerusalem
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K111736

    Owner / Operator

    Firm Name
    TUTTNAUER LTD.
    Operator Number
    8030087
    Address
    HAR-TUV B INDUSTRIAL ZONE
    City
    BEIT SHEMESH
    State
    Jerusalem
    Postal Code
    9910101
    Country
    IL

    US Agent

    Business Name
    Tuttnauer USA Co. Ltd.
    Contact Name
    Guy Lerner
    Address
    25 Power Drive Hauppauge New York
    City
    Hauppauge
    State
    NY
    ZIP
    11788
    Country
    US
    Email
    [email protected]
    Phone
    800 6245836

    Products

    Device Name Product Code
    Sterilizer, Steam FLE
    Indicator, Biological Sterilization Process FRC
    Indicator, Physical/Chemical Sterilization Process JOJ
    Device, Pasteurization, Hot Water LDS
    Indicator, Chemical, Enzymatic, Sterilization Process MTC

    Proprietary Names

    EZ9, EZ11, EZ15 - PLUS Tuttnauer Steam Sterilizer T-EDGE 10 & T-EDGE 11 Tuttnauer Steam Sterilizer Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye T-Top 10, T-Top 11 ELARAII Elara 11 T-Edge10 Tuttnaier Table Top Autoclave 6690, 66120, 69150, 6990, 69120, 69180 1730, 2340, 2540, 3870 E/EK/EP, EZ9, EZ10, 3870 E/M, 2340, 2540, 3870 EA/EKA Terragene Chemdye Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222- 1730, 2340, 2540, 3870 - E Tuttnauer Horizontal models 4472, 5596, 6690, 66120, 69120, 69180 4472, 5596 TIVA 2 &, TIVA 8 TIVA 2 &, TIVA 8, TIVA 10 ELARA11 T-Edge 11 3870HSG and 3870HSG-WS Tuttnauer Sterilization Process Indicator

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility