BEUDAMED
    FDA Registration Active 🇫🇷 France

    IMPLICITY

    Reg #: 3030125003 · FEI: 3030125003 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    IMPLICITY
    Registration Number
    3030125003
    FEI Number
    3030125003
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    29 rue du Louvre
    City
    Paris Ile-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K210543

    Owner / Operator

    Firm Name
    Implicity
    Operator Number
    10089468
    Address
    29 rue du Louvre
    City
    Paris
    State
    Ile-de-France
    Postal Code
    75002
    Country
    FR
    Correspondent
    Caroline Florequin

    US Agent

    Business Name
    Implicity
    Contact Name
    Jon Hunt
    Address
    4412 Fox Brook Ln
    City
    Charlotte
    State
    NC
    ZIP
    28211
    Country
    US
    Email
    [email protected]
    Phone
    949 6365835

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    Electrocardiograph DPS
    Adjunctive Predictive Cardiovascular Indicator QAQ
    Medium-Term Adjunctive Predictive Cardiovascular Indicator QNL

    Proprietary Names

    IM007 (ILR ECG Analyzer) SignalHF

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device