BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Rusch Pocket Pac

    Reg #: 8040412 · FEI: 3009271244 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Teleflex Medical Sdn. Bhd.
    Registration Number
    8040412
    FEI Number
    3009271244
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot PT 2577, Jalan Perusahaan 4
    City
    KAMUNTING Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K010420

    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
    Catheter, Urological KOD
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM

    Proprietary Names

    Rusch Pocket Pac MULTIPLE STERILE URETHRAL CATHET Convatec GentleCath Rusch Intermittent Insertion Kit Rusch MMG Closed System Intermittent Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device