BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    UroLift 2 System

    Reg #: 3009307931 · FEI: 3009307931 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    The Laryngeal Mask Company (M) SDN. BHD.
    Registration Number
    3009307931
    FEI Number
    3009307931
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot 19 , Jalan Hi-Tech 3, Zon Industri Fasa 1, Kulim Hi-Tech Park
    City
    Kulim Kedah
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K201837

    Owner / Operator

    Firm Name
    Teleflex
    Operator Number
    9062981
    Address
    3015 Carrington Mill Blvd.
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Divya Raman

    US Agent

    Business Name
    Teleflex, Inc.
    Contact Name
    Divya Raman
    Address
    3015 Carrington Mill Boulevard
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US
    Email
    [email protected]
    Phone
    612 4231738

    Products

    Device Name Product Code
    Implantable Transprostatic Tissue Retractor System PEW

    Proprietary Names

    UroLift 2 System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)