BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    THEO MANUFACTURING BV

    Reg #: 3007582648 · FEI: 3007582648 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    THEO MANUFACTURING BV
    Registration Number
    3007582648
    FEI Number
    3007582648
    Status
    Active
    Expiry Year
    2026
    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

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Caves Rd Ste 1 Ste 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device