BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    HSINER CO., LTD.

    Reg #: 3031369651 · FEI: 3031369651 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    44
    Establishment Types
    3
    Classifications
    26

    Registration Details

    Registration Name
    HSINER CO., LTD.
    Registration Number
    3031369651
    FEI Number
    3031369651
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 251, Sec.1,Houke Rd., Houli Dist.
    City
    Taichung City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K063268

    Owner / Operator

    Firm Name
    HSINER CO., LTD.
    Operator Number
    9053474
    Address
    312, Jhongshang Rd., Shengang Dist.
    City
    Taichung City
    State
    TW-TXG
    Postal Code
    429
    Country
    TW

    US Agent

    Business Name
    ROC Chinese-European Industrial Research Society
    Contact Name
    Shu-Chen Cheng
    Address
    2064 Tamarin Dr
    City
    Columbus
    State
    OH
    ZIP
    43235
    Country
    US
    Email
    [email protected]
    Phone
    614 5888168

    Products

    Device Name Product Code
    Mask, Oxygen, Low Concentration, Venturi BYF
    Mask, Oxygen BYG
    Tent, Oxygen BYL
    Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
    Ventilator, Non-Continuous (Respirator) BZD
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Connector, Airway (Extension) BZA
    Bag, Reservoir BTC
    Strap, Head, Gas Mask BTK
    Cannula, Nasal, Oxygen CAT
    Mouthpiece, Breathing BYP
    Nebulizer (Direct Patient Interface) CAF
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Filter, Bacterial, Breathing-Circuit CAH
    Humidifier, Non-Direct Patient Interface (Home-Use) KFZ
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Tubing, Pressure And Accessories BYX
    Mask, Oxygen, Non-Rebreathing KGB
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Ventilator, Continuous, Facility Use CBK
    Mask, Gas, Anesthetic BSJ
    Airway, Oropharyngeal, Anesthesiology CAE
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Drain, Tee (Water Trap) BYH

    Proprietary Names

    Venturi Mask (as part of oxygen mask group) Pulmogine® Adult Mask Aerosol Mask Child Oxygen Mask HSINER CPR Pocket Masks Aerosol Mask Adult Aerogen Go® Mask (Pediatric) Pulmogine® Pediatric Mask Aerogen Go® Mask (Adult) HSINER VARIOUS MOD Oxygen Administration Face Tent Anesthesia Breathing Circuit Kit (adult & pediatric) HSINER VARIOUS MODELS OF CPAP VPAP MASK Artificial Nose Airway Connector Breathing Bag Strap, Head, Gas Mask HSINER VARIOUS MODELS Pulmogine® Mouthpiece Aerosol Mouthpiece Aerogen Go® Mouthpiece Hsiner Nebulizer Bottle & GAS LINE ACCESSORIES; HSINER VARIOUS MODELS OF VENTILATOR Filters & Filtered HME HSINER Hsiner Humidifier Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) Oxygen Tubing and Accessories VALVE MASK COMBO VPAP Pediatric Face Mask HSINER CPAP SILICONE NASAL MASK SIZE XS PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA HSINER VARIOUS MODEL HSINER VARIOUS MODELS OF AIRWAY NIPPV ECONOMY FACE MASK SILICONE NASAL MASK NIPPV SILICONE FACE MASK The BAG PEEP Valve The BAG Manometer Water Trap

    Establishment Types

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