BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN URION TECHNOLOGY CO., LTD.

    Reg #: 3011654863 · FEI: 3011654863 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    37
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    SHENZHEN URION TECHNOLOGY CO., LTD.
    Registration Number
    3011654863
    FEI Number
    3011654863
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Floor 4th-6th of Building D , Jiale Science&Technology Industrial Zone, No.3 , ChuangWei Road ,Heshuikou, Community,MaTian St.,GuangMing New District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K260273

    Owner / Operator

    Firm Name
    Shenzhen Urion Technology Co., Ltd.
    Operator Number
    10049394
    Address
    Floor 4th-6th of Building D , Jiale Science&Technology Industrial Zone, No.3 , ChuangWei Road ,, Heshuikou Community,MaTian Street,GuangMing New District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518106
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Pump, Nebulizer, Electrically Powered JPW
    Massager, Therapeutic, Electric ISA
    Scale, Platform, Wheelchair INF
    Adult Portable Bed Rails For Medical Purposes QTC
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Massager, Powered Inflatable Tube IRP
    Continuous Measurement Thermometer FLL
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    Nebulizer ISA - Neck massager,therapeutic,electric ISA - Leg Massager, therapeutic, electric BED RAIL Upper Arm Electronic Blood Pressure Monitor U90B, U90B Pro, U90B Plus, U90B Ultra Automatic Electronic Blood Pressure Monitor U90C, U90C Pro, U90C Plus, U90C Ultra Upper Arm Electronic Blood Pressure Monitor U90C, U90C Pro, U90C Plus, U90C Ultra Automatic Electronic Blood Pressure Monitor U90B, U90B Pro, U90B Plus, U90B Ultra Air Compression Leg Massager (UM605,UM606, UM607,UM608,UM609,UM610,UM611,UM617) Andesfit Ltd ADF-B33A UFR103,UFR116,UFR205,UFR105,UFR201 UFR102 Red Light Support Belt RL 450, RL 450G, RL 450B, RL 600, RL 600G, RL 600B, G78B, G15 Red Light Belt RL 500, RL 500B, RL 500G, RL 550, RL 550B, RL 550G, G78 BU A55,BU A57,BU 510,BU 512,BU 514,BU 516 ZYBS MEDICAL UPPER ARM ELECTRONIC MONITOR MODEL: U80B U82W, U807, U81Q, U80W, U80G Upper Arm Electronic Blood Pressure Monitor U80A,U80AH,U80B,U80BH U80M,U81M,U82H,U83H,U85H U80L,U80T,U81K,U80CH,U81CH,U80I U80K,U80NH,U80R,U80IH,U81H,U80H,U80LH,U82NH U80C U90E,U91E,U92E,U90F,U91F,U92F,U80V,U82V Medisana upper arm blood pressure monitor BU 630 U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) U81CH, U81V, U91X, U91X, U99X, U91P, U97P, U99P Upper Arm Electronic Blood Pressure Monitor U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH) U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ) U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z) Wrist Electronic Blood Pressure Monitor U60A,U60AH,U60CH,U60EH,U60BH,U60GH,U61GH,U62GH,U62I,U63I,U60B,U60C,U60EandU60I U60H U60G Andesfit Ltd ADF-B103W Wrist Watch Electronic Blood Pressure Monitor U16H, U16L, U16P, U16W, U19M, U19R, U19S and U19T Upper Arm Electronic Blood Pressure Monitor U85E, U86E, TelliBP01 U80D Andesfit Ltd ADF-B180

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device