BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    L-Mesitran Border

    Reg #: 3007582648 · FEI: 3007582648 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    THEO MANUFACTURING BV
    Registration Number
    3007582648
    FEI Number
    3007582648
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Sleperweg 44
    City
    Maastricht Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K053613

    Owner / Operator

    Firm Name
    THEO MANUFACTURING BV
    Operator Number
    10028046
    Address
    Sleperweg 44
    City
    Maastricht
    State
    Limburg
    Postal Code
    6222 NK
    Country
    NL
    Correspondent
    Josephus Postmes

    US Agent

    Business Name
    Sion Brands, LLC
    Contact Name
    Sandra Baldenegro
    Address
    1214 Beltway Parkway
    City
    Laredo
    State
    TX
    ZIP
    78045
    Country
    US
    Email
    [email protected]
    Phone
    956 2206832

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    L-Mesitran Border L-Mesitran Net L-Mesitran Hydro L-Mesitran Active Gentell Honey Hydrogel 7 X 5 Gentell Honey Hydrogel 2.4 X 2.4 Gentell Honey Hydrogel 4.7 X 3.4

    Establishment Types

    Foreign Private Label Distributor Manufacture Medical Device