BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    The Hygenic Corporation

    Reg #: 9681338 · FEI: 3003123739 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    52
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    The Hygenic Corporation
    Registration Number
    9681338
    FEI Number
    3003123739
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Plot 6 Bemban Industrial Park
    City
    Batu Gajah Perak
    Country
    MY

    Owner / Operator

    Firm Name
    The Hygenic Company, LLC
    Operator Number
    1519375
    Address
    1245 Home Ave
    City
    Akron
    State
    OH
    Postal Code
    44310
    Country
    US
    Correspondent
    Melanie - Leibowitz

    Products

    Device Name Product Code
    Tourniquet, Nonpneumatic GAX
    Bandage, Elastic FQM
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Dam, Rubber EIE
    Exerciser, Non-Measuring ION

    Proprietary Names

    BD Stretch Tourniquet Strap Hygenic Hysynal Tourniquet Strap Underwrap Tape EcoFlex Stretch Tape Self-Stick Tape Bulk HYSNAL Accessory Leg Strap Flexi Dam Non-Latex Framed Flexi Dam Non-Latex NON-LATEX DENTAL DAM Rubber Dam Elasti-Dam Fiesta Dental Dam HYGENIC DENTAL DAM TheraBand Sheeting Latex (includes Loops and High Resistance) (all configurations) TheraBand Tubing TheraBand Hand Xtrainer TheraBand Hand Trainer TheraBand Stability Trainer TheraBand Stability Disk TheraBand Standard Roller Massager TheraBand Aquafins Aquatic Exercise Kit TheraBand Rocker Boards TheraBand Flexbar TheraBand Portable Roller Massager TheraBand Hand Bar with Padded Grip TheraBand Soft Weights TheraBand Exercise Balls TheraBand Exercise Station TheraBand Webbed Pull Buoy Swim Training Aid TheraBand Stretch Strap TheraBand Wobble Boards TheraBand Swim Bar with Padded Grip TheraBand Hand Exerciser TheraBand Mini Ball TheraBand Roller Wraps TheraBand Shoulder Pulley Young Swim Belt with High-Density Buoyancy Foam TheraBand Foot Roller TheraBand Kickroller Floatation Device with Padded Grip TheraBand Closed Chain Buoyancy Disk TheraBand Sheeting Non-Latex TheraBand Half Round Roller Round Roller (12" and 36") CLX Station Anchors Rolyan Exercise Band Rolyan Door Anchor Stirrup Rolyan Exercise Tubing Theraband Therapy Putty Rolyan Therapy Putty Theraband Anchor Rolyan Ergonomic Hand Exerciser

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device