BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    EP Tracer

    Reg #: 3008329188 · FEI: 3008329188 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARDIOTEK BV
    Registration Number
    3008329188
    FEI Number
    3008329188
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Dr. Nolenslaan 107B
    City
    GL SIttard Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K134044

    Owner / Operator

    Firm Name
    Schwarzer Cardiotek GmbH
    Operator Number
    10048719
    Address
    Im Zukunftspark 3
    City
    Heilbronn
    State
    Baden-Wurttemberg
    Postal Code
    74076
    Country
    DE
    Correspondent
    Fritz C Vollmer

    US Agent

    Business Name
    Graematter, Inc
    Contact Name
    Melissa Walker
    Address
    225 W Crockett St
    City
    De Kalb
    State
    TX
    ZIP
    75559
    Country
    US
    Email
    [email protected]
    Phone
    636 4057498

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    EP Tracer

    Establishment Types

    Manufacture Medical Device