BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    Kolplast Ci Ltda

    Reg #: 8044093 · FEI: 3005729015 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    Kolplast Ci Ltda
    Registration Number
    8044093
    FEI Number
    3005729015
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Estrada Municipal Benedito De Souza, #418 Bairro Da Mina
    City
    Itupeva Sao Paulo
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K110766

    Owner / Operator

    Firm Name
    Kolplast CI Ltda
    Operator Number
    9005455
    Address
    Estrada Municipal Benedito De Souza, #418 Bairro Da Mina
    City
    Itupeva
    State
    Sao Paulo
    Postal Code
    13299-364
    Country
    BR

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Slides, Microscope KEW
    Lamp, Surgical FTD
    Speculum, Vaginal, Nonmetal HIB
    Speculum, Rectal FFQ
    Spatula, Cervical, Cytological HHT
    Culture Media, Non-Selective And Non-Differential JSG
    Filters, Cell Collection, Tissue Processing KET
    Applicator, Absorbent Tipped, Sterile KXG
    Cytocentrifuge IFB
    Preservative, Cytological LEA

    Proprietary Names

    CellPreserv Glass Slide Kolplux WL System KOLPLUX System Kolplast Vaginal Speculum Kolplast Rectosigmoidoscope Kolplast Cervical Sample Collection Kit Viral Transport Saline Solution Kolplux Vaginal Speculum CellPreserv Filter Swab Kolplast CELLPRESERV CYTOCENTRIFUGE CellPreserv Preservation Solution

    Establishment Types

    Manufacture Medical Device