BEUDAMED
    FDA Registration Active 🇨🇳 China

    XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD

    Reg #: 3008393409 · FEI: 3008393409 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    29
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD
    Registration Number
    3008393409
    FEI Number
    3008393409
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Kernel Mansion, Economic Development District
    City
    Xuzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K160341

    Owner / Operator

    Firm Name
    XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD
    Operator Number
    10046889
    Address
    Kernel Mansion, Economic Development District
    City
    Xuzhou
    State
    Jiangsu
    Postal Code
    221004
    Country
    CN
    Correspondent
    Wei Zhao

    US Agent

    Business Name
    Humiss Inc.
    Contact Name
    James St. Wu
    Address
    1500 N Grant St Ste R
    City
    Denver
    State
    CO
    ZIP
    80203
    Country
    US
    Email
    [email protected]
    Phone
    720 7595888

    Products

    Device Name Product Code
    Colposcope (And Colpomicroscope) HEX
    Light, Wood'S, Fluorescence GMB
    Light, Ultraviolet, Dermatological FTC
    Powered Laser Surgical Instrument GEX
    Laser, Comb, Hair OAP
    Over-The-Counter Powered Light Based Laser For Acne OLP
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    Colposcope System KN-2200,KN-2200A,KN-2200B,KN-2200B1,KN-2200I,KN-2200I(H) KN-9000A KN-9000B KN-4001/KN-4002/KN-4003/KN-4004/ KN4005/KN4006 KN-4003AL,KN-4003B,KN-4003BL,KN-4006AL,KN-4006B,KN-4006BL UV PHOTOTHERAPY UV Phototherapy JuveLight LED Light Therapy Device iLight LED Pro 308nm Excimer Phototherapy Device CN-308E KN-4003B3 KN-4003B4 KN-5000C KN-5000D KN-5000H KN-5000K Hair Growth System Device (Model: KN-8000A) FolliLight POLY Go Hair Growth System Model: KN-8000B; KN-8000C; KN-8000D; KN-8000E, POLY Pro Regen POLY Pro ULTRA Regen PHOCUS-PRO PHOCUS-ULTRA 308nm Excimer System KN-5000C,KN-5000D ExciLight UV phototherapy KN-4003AL2,KN-4003BL2,KN-4003AL2D,KN-4003BL2D,KN-4006AL1,KN-4006BL1,KN-4006AL1D,KN-4006BL1D POLY Clear POLY Regen POLY Rejuv

    Establishment Types

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