BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    (CYV-100-5; CYV-101-5) LiNA CystoVu™ HD

    Reg #: 3008693678 · FEI: 3008693678 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LiNA Medical AG
    Registration Number
    3008693678
    FEI Number
    3008693678
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Platz 3
    City
    Root D4 Luzern
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K240227

    Owner / Operator

    Firm Name
    LiNA Medical AG
    Operator Number
    10033967
    Address
    Platz 3
    City
    Root D4
    State
    Luzern
    Postal Code
    6039
    Country
    CH
    Correspondent
    Jaroslaw Mrowczynski

    US Agent

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

    Products

    Device Name Product Code
    Cystoscope And Accessories, Flexible/Rigid FAJ

    Proprietary Names

    (CYV-100-5; CYV-101-5) LiNA CystoVu™ HD (SCP-100-1) LiNA ScopeVu™

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device