BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    The Laryngeal Mask Company (M) SDN. BHD.

    Reg #: 3009307931 · FEI: 3009307931 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    40
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    The Laryngeal Mask Company (M) SDN. BHD.
    Registration Number
    3009307931
    FEI Number
    3009307931
    Status
    Active
    Expiry Year
    2026
    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
    K242495

    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
    Tube, Tracheal (W/Wo Connector) BTR
    Airway, Oropharyngeal, Anesthesiology CAE
    Implantable Transprostatic Tissue Retractor System PEW
    Cuff, Tracheal Tube, Inflatable BSK

    Proprietary Names

    LMA Fastrach ETT SU LMA ProSeal LMA Fastrach (SU) LMA Unique (Silicone Cuff) LMA Supreme LMA Flexible (SU) Oropharyngeal Guedel Tube Black LMA Cuff-Deflator LMA Unique (Silicone Cuff) Cuff Pilot LMA ProSeal Introducer LMA Unique Evo Cuff Pilot LMA Protector Cuff Pilot LMA Fastrach LMA Flexible LMA ProSeal Cuff Deflator LMA Protector LMA Unique Evo LMA Classic Excel LMA Unique LMA Gastro Cuff Pilot LMA Unique PreCurved LMA Classic LMA Flexible PreCurved LMA Unique PreCurved Cuff Pilot LMA NovaPlus LMA Supreme Plus Pack LMA Flexible PreCurved Cuff Pilot MADgic Airway LMA Fastrach Stabiliser Rod LMA Unique (S) Cuff Pilot LMA Flexible (S) LMA Unique (S) LMA Flexible (S) Cuff Pilot Cath-Guide Guedel Airway Airway Lifesaver Kit Ovassapian Airway Dual Channel Airway UroLift 2 System Cuff Pilot LMA Fastrach ETT

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)