BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Teleflex Medical Sdn. Bhd.

    Reg #: 8040412 · FEI: 3009271244 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    85
    Establishment Types
    2
    Classifications
    16

    Registration Details

    Registration Name
    Teleflex Medical Sdn. Bhd.
    Registration Number
    8040412
    FEI Number
    3009271244
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lot PT 2577, Jalan Perusahaan 4
    City
    KAMUNTING Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K952084

    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
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Catheter, Urethral GBM
    Catheter, Urological KOD
    Catheter, Retention Type, Balloon EZL
    Tube, Tracheal (W/Wo Connector) BTR
    Catheter, Coude EZC
    Connector, Airway (Extension) BZA
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Filter, Bacterial, Breathing-Circuit CAH
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    Device, Fixation, Tracheal Tube CBH
    Stylet, Tracheal Tube BSR
    Airway, Nasopharyngeal BTQ
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Catheter, Balloon Type GBA
    Tube Tracheostomy And Tube Cuff JOH

    Proprietary Names

    FILTER, BACTERIAL, BREATHING-CIRCUIT Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter RUSCH BRILLANT SILICONE FOLEY Tracheal Tube MULTIPLE URETHRAL CATHETERS Rusch MMG H2O Bladder Catheter Tiemann Rusch FloCath Quick 18 Fr. Coude Hydrophilic Intermittent Catheter Oral/Nasal Safety Clear Trache tube cuffed, magill/murphy Y Connector Elbow Connector M Connector Connector Sher-I-Swiv Double Swivel Connector CPRAM Respiratory Assist Device Hudson RCI Adaptors and Connectors Rusch Connector Oxygenator Rusch Connector Trach Tee Fitting Hudson RCI Tubing Hudson RCI Sensor Tee Rusch Connector with Barbed Elbow Nelaton catheter rubber, cylindrical / Robinson pattern / whistle tip / coaxial / Tiemann pattern Nelaton-Robinson catheter, Tiemann pattern Female catheter Nelaton-Robinson catheter, cylindrical Rusch all purpose red rubber Rusch Silicone Coated Foley, and pediatric Rusch all purpose Robinson / Nelation ERU Catheter PVC Tiemann Pattern AGT PVC Preform Oral trachea tube cuffed w/mur eye Hudson Sampling Lines and Filters Gas Sampling Lines Multiple Ventilator T Corr A Tube Smooth Flo Corr A Tube II Corr A Flex Rusch Sampling Lines, Rusch Anesthesia Circuit Accessories Catheter Mount Rusch Corrugated Tubing Venti-Comp Gibeck RCI SOFTFLEX Hudson Anesthesia Circuit Assessories Iso-Gard Filter Angled/Iso-Gard Filter Straight Standard Connector Humid Vent HEPA RuSCH SILICONE FOLEY CATHETER Teleflex Convatec GentleCath MULTIPLE STERILE URETHRAL CATHET Rusch Intermittent Insertion Kit Rusch MMG Closed System Intermittent Catheter Rusch Pocket Pac Rusch Endotracheal Tube Holder Soft Foam Mouth Cushions Trach collar Sheridan Soft-Tip Intubating Stylet Sher-I-Swiv/FO Double Swivel Connector Sheridan Sher-I-Slip Intubating Stylet Rusch Endotracheal Tube Stylet Rusch FloCath Quick kit, Female Rusch FloCath Quick Rusch Standard FloCath Flocath and Easycath Intermittent Catheter ISO-GARD HEPA FILTER-HME ISO-ARD HEPA FILTER-HME W/PORT Rusch Latex Gold Foley Catheter HUMID-VENT HEAT AND MO MULTIPLE HEAT HUMID-FLO MOISTURE ARTIFICIAL NOSE CONDENSER HEAT AND MOISTURE VARIOUS TYPES OF HEAT AND MOISTURE EXCHANGERS RUSCH AGT PVC PREFORM NASAL Nasopharyngeal tube rubber, Wendl pattern HUMID-VENT FILTER SMALL HUMID-VENT FILTER COMPACT Rusch Endobronchial Tubes MULTIPLE BREATHING CIR Bacterial/Viral Filter Hudson RCI Main Line Filter Kit Humid-Vent Filter BALLOON TYPE MULTIPLE BALLOON TYPE CATHETERS Multiple Tracheal Tubes W/O Connect LMA Fastrach ETT SU Rusch Simplastic Foley Catheters AGT PVC Preform Nasal trachea tube uncuff w/ mur eye TracheoFix-Set

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility