BEUDAMED
    FDA Registration Active 🇨🇳 China

    NINGBO LUKE MEDICAL DEVICES CO., LTD.

    Reg #: 3013909820 · FEI: 3013909820 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    47
    Establishment Types
    3
    Classifications
    27

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    Registration Details

    Registration Name
    NINGBO LUKE MEDICAL DEVICES CO., LTD.
    Registration Number
    3013909820
    FEI Number
    3013909820
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gujiayan, Yangming Road, 315400 Yuyao City, Zhejiang Province, China
    City
    Yuyao Zhejiang
    Country
    CN

    Owner / Operator

    Firm Name
    Ningbo Luke Medical Devices Co., Ltd.
    Operator Number
    10056138
    Address
    Gujiayan, Yangming Road, 315400 Yuyao City, Zhejiang Province, China
    City
    Yuyao
    State
    Zhejiang
    Postal Code
    315400
    Country
    CN
    Correspondent
    Yehua Zhang

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Vibrator For Therapeutic Use, Genital KXQ
    Strap, Head, Gas Mask BTK
    Bag, Reservoir BTC
    Airway, Nasopharyngeal BTQ
    Accessories, Catheter KGZ
    Non-Surgical Gown OEA
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Cannula, Surgical, General & Plastic Surgery GEA
    Mask, Scavenging KHA
    Accessory, Surgical Apparel LYU
    Enteral Administration Kit (Adult & Pediatric) PRM
    Snare, Surgical GAE
    Mask, Oxygen BYG
    Mask, Oxygen, Non-Rebreathing KGB
    Mask, Oxygen, Low Concentration, Venturi BYF
    Cannula, Nasal, Oxygen CAT
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Mask, Gas, Anesthetic BSJ
    Airway, Oropharyngeal, Anesthesiology CAE
    Stirrups EYD
    Cup, Menstrual HHE
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Catheter, Irrigation GBX
    Needle, Catheter GCB
    Brush, Cleaning, Tracheal Tube EPE
    Catheter And Tip, Suction JOL

    Proprietary Names

    Kegel Ball Headgear Latex free breathing bag Nasopharyngeal Airway Drainage Tubes Drainage Bag Isolation Gown Wound Drainage Systems PVC wound drainage system, PVC reservoirs Nebulize Mask CPAP Tube Disposable Breathing Circuits Face Mask Face Shield stomach tube (Gastric Calibration Tube ) Silicone Loops Oxygen Masks CPAP Mask Aerosol Non-breathing Oxygen Mask Venturi Mask Nasal Oxygen Cannulas Disposable Face Mask Anesthesia Mask Laryngeal Mask Airways Oropharyngeal Airway Heat and Moisture Exchangers Canack Cup Cuttie cup Luna Cup First greener cup Serene Cup Noble Cup Menstrual Vivi Cup SABA Menstrual Cup Luke Cup Menstrual Disc. Luke Menstrual Disc. Floren Menstrual Cup Canack Menstrual Disc. Vivi menstrual disc. Protective Goggles Silicone Reservoirs PVC/Silicone wound drainage tube Tracheal Tube Suction Tubing with Yankauer Handle

    Establishment Types

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