BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    FOREMOUNT ENTERPRISE CO., LTD.

    Reg #: 3010402691 · FEI: 3010402691 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    50
    Establishment Types
    4
    Classifications
    30

    Registration Details

    Registration Name
    FOREMOUNT ENTERPRISE CO., LTD.
    Registration Number
    3010402691
    FEI Number
    3010402691
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 257, Sec. 5, Changping Rd., Shengang District
    City
    Taichung City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K002846

    Owner / Operator

    Firm Name
    FOREMOUNT ENTERPRISE CO., LTD.
    Operator Number
    9042153
    Address
    No.17, Alley 15, Lane 5,, Shenan Street, Shengang District
    City
    Taichung City
    State
    TW-TXG
    Postal Code
    429
    Country
    TW
    Correspondent
    William - Jiang

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Mask, Gas, Anesthetic BSJ
    Polymer Patient Examination Glove LZA
    Stylet, Tracheal Tube BSR
    Mask, Oxygen, Low Concentration, Venturi BYF
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Cannula, Nasal, Oxygen CAT
    Valve, Non-Rebreathing CBP
    Airway, Oropharyngeal, Anesthesiology CAE
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Humidifier, Non-Direct Patient Interface (Home-Use) KFZ
    Bag, Reservoir BTC
    Nebulizer (Direct Patient Interface) CAF
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Tubing, Pressure And Accessories BYX
    Filter, Bacterial, Breathing-Circuit CAH
    Gag, Mouth KBN
    Laryngoscope, Rigid CCW
    Strap, Head, Gas Mask BTK
    Accessory Equipment, Cardiopulmonary Bypass KRI
    Connector, Airway (Extension) BZA
    Holding Chambers, Direct Patient Interface NVP
    Mouthpiece, Breathing BYP
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Clip, Nose BXJ
    Mask, Oxygen BYG
    Mask, Oxygen, Non-Rebreathing KGB
    Infusor, Pressure, For I.V. Bags KZD

    Proprietary Names

    Resuscitator W/Peep Valve PVC Resuscitator and Accessories Manual Resuscitator, BVM Antistatic Silicone Face Mask; Silicone Face Mask Anesthetic mask;EZ mask;Cushion mask; Face mask; Silicone mask; Flexichamber face mask; Anesthesia mask, Rotation Mask Anesthesia Face mask NBR (Nitrile Rubber) glove Introducer Vented Tracheal Tube Introducers (Bougie) Bougie Venturi Mask Large Volume Nebulizer Nasal cannula Pocket size resuscitator Emergency response mask CPR Mask BERMAN AIRWAYS Airway OROPHARYNGEAL DYNACOR AIRWAYS GUEDEL AIRWAYS Ventilator tubing HUMIDIFIER Air Breathing Bag Reservoir Bag Bag NEBULIZER Anesthesia Circuit Anesthesia breathing circuit Anesthesia Circuit Accessories Oxygen tubing HMEF,FILTER Mouth screw Mouth opener Laryngoscope blade Head harness Head Strap Chamber valve Oxygen barb, Oxygen Adapter, Christmas Tree Adapter Antistatic Compact Space Chamber; Asthma Chamber Compact Space Chamber Plus; Space Chamber Plus Mouthpiece HME Nose clip Aerosol mask Infant cluster mask CPR face shield, Panda mask Pressure Infusor Bag PIB

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device