BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MiYO Esthetic System

    Reg #: 1219645 · FEI: 1219645 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    JENSEN INDUSTRIES, INC.
    Registration Number
    1219645
    FEI Number
    1219645
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    50 STILLMAN RD.
    City
    NORTH HAVEN
    State
    CT
    ZIP
    06473
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111743

    Owner / Operator

    Firm Name
    JENSEN INDUSTRIES, INC.
    Operator Number
    1219645
    Address
    50 STILLMAN RD., --
    City
    North Haven
    State
    CT
    Postal Code
    06473
    Country
    US

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    MiYO Esthetic System MiYO Pink InSync Ceramic System MiYO 850

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device