BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    UltraCW®II Automatic Cell Washing System

    Reg #: 3004086278 · FEI: 3004086278 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HETTICH AG
    Registration Number
    3004086278
    FEI Number
    3004086278
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SEESTRASSE 204A
    City
    BAECH Schwyz
    Country
    CH

    Regulatory Submissions

    510(k) Number
    BK170141

    Owner / Operator

    Firm Name
    HETTICH AG
    Operator Number
    9057280
    Address
    SEESTRASSE 204A, --
    City
    BAECH
    State
    CH-NOTA
    Postal Code
    8806
    Country
    CH

    US Agent

    Business Name
    HELMER INC.
    Contact Name
    RENEE SCHULTZ
    Address
    14400 Bergen blvd
    City
    Noblesville
    State
    IN
    ZIP
    46060
    Country
    US
    Email
    [email protected]
    Phone
    317 7739073

    Products

    Device Name Product Code
    Centrifuge, Cell-Washing, Automated For Immuno-Hematology KSN

    Proprietary Names

    UltraCW®II Automatic Cell Washing System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)