BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IPure Preloaded IOL System (Models B1PY)

    Reg #: 1211998 · FEI: 1211998 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Beaver-Visitec International, Inc.
    Registration Number
    1211998
    FEI Number
    1211998
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    303 Wyman St Ste 350
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US

    Regulatory Submissions

    PMA Number
    P080004

    Owner / Operator

    Firm Name
    Beaver-Visitec International, Inc.
    Operator Number
    10033379
    Address
    500 Totten Pond Rd, 10 CityPoint
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    Intraocular Lens HQL

    Proprietary Names

    IPure Preloaded IOL System (Models B1PY) iPure Preloaded IOL System (Models B3PY) iPure Preloaded IOL System (Models B3PC) IPure Preloaded IOL System (Models B1PC)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198