BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    IC-8 Apthera IOL

    Reg #: 3016942176 · FEI: 3016942176 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOTECH EUROPE MEDITECH INC LTD
    Registration Number
    3016942176
    FEI Number
    3016942176
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AF2 IDA Business and Technology Park, Gallowstown
    City
    Roscommon
    Country
    IE

    Regulatory Submissions

    PMA Number
    P210005

    Owner / Operator

    Firm Name
    Biotech Europe Meditech Inc Ltd
    Operator Number
    10085821
    Address
    AF 2, IDA Business & Technology Park,, Gallowstown,
    City
    Roscommon
    State
    IE-RN
    Postal Code
    F42P862
    Country
    IE
    Correspondent
    Sai Praveen Duddukuru

    US Agent

    Business Name
    Bausch & Lomb Incorporated
    Contact Name
    Ramesh Sedhain
    Address
    21 N Park Place Blvd
    City
    Clearwater
    State
    FL
    ZIP
    33759
    Country
    US
    Email
    [email protected]
    Phone
    727 7246729

    Products

    Device Name Product Code
    Extended Depth Of Focus Intraocular Lens POE

    Proprietary Names

    IC-8 Apthera IOL

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)