BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    MINITUBE AB

    Reg #: 8032009 · FEI: 3001697252 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    MINITUBE AB
    Registration Number
    8032009
    FEI Number
    3001697252
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Byvagen 44
    City
    TRANGSVIKEN Jamtland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K211026

    Owner / Operator

    Firm Name
    MINITUBE AB
    Operator Number
    8032009
    Address
    BYVAGEN 44, --
    City
    TRANGSVIKEN
    State
    SE-NOTA
    Postal Code
    835 96
    Country
    SE

    US Agent

    Business Name
    mdi Consultants, Inc.
    Contact Name
    Alan Schwartz
    Address
    55 Northern Blvd Ste 200
    City
    Great Neck
    State
    VA
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Dental Barriers And Sleeves PEM
    Unit, Operative Dental, Accessories NRD
    Continuous Measurement Thermometer FLL

    Proprietary Names

    RINN® Tight Sensor Cover –Size 1 RINN® Large Digital Sensor Covers (Soft Overbag Cover) RINN® Tight Digital Sensor Cover –Size 1.5/2 RINN® Tight Digital Sensor Cover - Size 1 Barrier sleeves Dentasleeve Minitube X-Ray Sensor Sheath Intraoral Camera Sheath MEDLINE LUBRICATED THERMOMETER SHEATH Medline thermometer sleeves BLUEPHASE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device