BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    GESTENCO INTERNATIONAL AB

    Reg #: 3004109528 · FEI: 3004109528 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    GESTENCO INTERNATIONAL AB
    Registration Number
    3004109528
    FEI Number
    3004109528
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    FRIDKULLAGATAN 14
    City
    GOTEBORG Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K981036

    Owner / Operator

    Firm Name
    Gestenco International AB
    Operator Number
    9028524
    Address
    14 Fridkullagatan, --
    City
    Gothenburg
    State
    SE-NOTA
    Postal Code
    SE 412 62
    Country
    SE
    Correspondent
    Matteo - Catenacci

    US Agent

    Business Name
    Obelix Consulting
    Contact Name
    Elisa Maldonado-Holmertz
    Address
    806 Jefferson St
    City
    Bastrop
    State
    TX
    ZIP
    78602
    Country
    US
    Email
    [email protected]
    Phone
    512 4316069

    Products

    Device Name Product Code
    Protector, Dental BRW
    Instruments, Dental Hand DZN
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Bracket, Metal, Orthodontic EJF
    Accessories, Retractor, Dental EIF
    Bracket, Plastic, Orthodontic DYW

    Proprietary Names

    Plucker Aligner Remover Rodneys Aligner Seaters Springtime C Vitrine

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198