BEUDAMED
    FDA Registration Active 🇵🇹 Portugal

    K Line Portugal Unipessoal Ltd

    Reg #: 3033492726 · FEI: 3033492726 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    2

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    Registration Details

    Registration Name
    K Line Portugal Unipessoal Ltd
    Registration Number
    3033492726
    FEI Number
    3033492726
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Estrada de Braga, Lugar de S.Fausto, Armazem 4
    City
    Chaves Braga
    Country
    PT

    Regulatory Submissions

    510(k) Number
    K220726

    Owner / Operator

    Firm Name
    K LINE EUROPE GMBH
    Operator Number
    10079939
    Address
    Bonner Strasse 203-393, SEGRO Park Dusseldorf-Sud, Section 203 K
    City
    Dusseldorf-Benrath
    State
    North Rhine-Westphalia
    Postal Code
    40589
    Country
    DE
    Correspondent
    Sherif Kandil

    US Agent

    Business Name
    Aclivi, LLC
    Contact Name
    Chris Brown
    Address
    405 Tropics Ave
    City
    Daytona Beach
    State
    FL
    ZIP
    32124
    Country
    US
    Email
    [email protected]
    Phone
    810 3609773

    Products

    Device Name Product Code
    Aligner, Bracket, Orthodontic ECQ
    Aligner, Sequential NXC

    Proprietary Names

    K Clear CLEAR X

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)