BEUDAMED
    FDA Registration Active 🇨🇳 China

    Essentia Industries Ltd.

    Reg #: 3009124884 · FEI: 3009124884 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    36
    Establishment Types
    4
    Classifications
    31

    Registration Details

    Registration Name
    Essentia Industries Ltd.
    Registration Number
    3009124884
    FEI Number
    3009124884
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 2, No. 94, Yanhe East 1st Road, DongKeng Town
    City
    Dong Guan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K984551

    Owner / Operator

    Firm Name
    ALLIED HILL ENTERPRISES, LTD.
    Operator Number
    9101920
    Address
    STE 507, TOWER 1, SILVERCORD, 30 CANTON RD T.S.T.
    City
    KOWLOON
    State
    HK-NOTA
    Postal Code
    --
    Country
    HK

    US Agent

    Business Name
    PW Resources, Inc.
    Contact Name
    Paul Ware
    Address
    578 Tarrant Crossing
    City
    Kernersville
    State
    NC
    ZIP
    27284
    Country
    US
    Email
    [email protected]
    Phone
    617 5137253

    Products

    Device Name Product Code
    Shield, Nipple HFS
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Continuous Measurement Thermometer FLL
    Pick, Massaging JET
    Pill Crusher/Cutter OHY
    Container, Liquid Medication, Graduated KYW
    Pump, Breast, Non-Powered HGY
    Syringe, Ent KCP
    Toothbrush, Powered JEQ
    Syringe, Irrigating (Non Dental) KYZ
    Toothbrush, Manual EFW
    Bandage, Elastic FQM
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Mirror, Mouth EAX
    Tip, Rubber, Oral Hygiene JEW
    Pump, Breast, Powered HGX
    Catheters, Suction, Tracheobronchial BSY
    Sling, Arm ILI
    Strip, Temperature, Forehead, Liquid Crystal KPD
    Ring, Teething, Non-Fluid Filled MEF
    Scissors, Medical, Disposable JOK
    Otoscope ERA
    Massager, Therapeutic, Manual LYG
    Massager, Therapeutic, Electric ISA
    Ring, Teething, Fluid-Filled KKO
    Dispenser, Solid Medication NXB
    Dispenser, Liquid Medication KYX
    Pack, Hot Or Cold, Reusable IME
    Reminder, Medication NXQ
    Cover, Cast KIA

    Proprietary Names

    Nipple Shields cotton applicator arm/leg splint digital thermometer GUM STIMULATOR pill cutter medicine spoon Silicone Breast Pump Limerick LOVE Hand Pump medicine dropper GENTLE VIBRATIONS TOOTHBRUSH Medicine dispensing syringe Toothbrush stretch bandage Nasal Aspirator DENTAL MIRROR baby mouth mirror Oral Care Kits PJ's Comfort Portable Electric Breast Pum Nasal aspirator arm sling forehead thermometer strip Doctor Brown Teether (normal) baby scsissors digital ear thermometer Gum massager PJ's Serenity powered massager Handi-craft waterfill teether Sassy Waterfill teethers pill dispenser Medicine syringe medicine pacifier cold compress medication minder cast cover

    Establishment Types

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