BEUDAMED
    FDA Registration Active 🇨🇳 China

    DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY

    Reg #: 9680357 · FEI: 3004829691 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    42
    Establishment Types
    3
    Classifications
    30

    Registration Details

    Registration Name
    DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY
    Registration Number
    9680357
    FEI Number
    3004829691
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 17, Banhu Rd, /No.54 Hong Sheng Road, Diao Lang Village, Huang Jiang Town,
    City
    DONG GUAN CITY Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K172963

    Owner / Operator

    Firm Name
    DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY
    Operator Number
    9008465
    Address
    BAN HU INDUSTRIAL DISTRICT, Huang Jiang Town
    City
    Dongguan,
    State
    Guangdong
    Postal Code
    523753
    Country
    CN
    Correspondent
    SHERRY - HUANG

    US Agent

    Business Name
    MAYTEX CORP.
    Contact Name
    GARY WANG
    Address
    23521 FOLEY ST.
    City
    HAYWARD
    State
    CA
    ZIP
    94545
    Country
    US
    Email
    [email protected]
    Phone
    510 8874888 ext. 0

    Products

    Device Name Product Code
    Dressing, Compression MHW
    Gown, Surgical FYA
    Mask, Surgical FXX
    Gown, Examination FME
    Device, Fixation, Tracheal Tube CBH
    Respirator, Surgical MSH
    Drape, Surgical, Exempt PUI
    Bandage, Cast ITG
    Drape, Pure Latex Sheet, With Self-Retaining Finger Cot EYX
    Cover, Cast KIA
    Bedding, Disposable, Medical KME
    Wrap, Sterilization FRG
    Non-Surgical Gown OEA
    Dressing, Wound, Drug FRO
    Fiber, Medical, Absorbent FRL
    Surgical Instruments, G-U, Manual (And Accessories) KOA
    Table, Cysto, Non-Electrical EYH
    Drape, Surgical, Antimicrobial KKX
    Cover, Shoe, Operating-Room FXP
    Dressing, Wound, Hydrophilic NAC
    Plastic Surgery And Accessories Kit FTN
    General Surgery Tray LRO
    Cap, Surgical FYF
    Suit, Surgical FXO
    Tray, Surgical LRP
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Cover, Barrier, Protective MMP
    Dressing, Wound, Occlusive NAD
    Tray, Surgical, Needle FSH
    Accessory, Surgical Apparel LYU

    Proprietary Names

    Dressing Compression L4 surgical gowns Face Mask Prevention Plus gown PP Gown LAB JACKET Tracheal tube fixation device N95 Particulate Respirator surgical drape Bandage, cast Bandage, Cast DRAPE SHEET Surgical mask with Fluid Shield Particulate Respirator cover bedding Surgical mask Sterilization Wrap PE Coated Gowns Dressing ABSORBENT TOWEL surgical instrument DRAIN BAG POUCH Surgical Drapes Surgical Dapes NON-SKID SHOE COVER Hydrophilic Dressing Wound Accessories Kit UNIVERSAL I PACK DISPOSABLE BOUFFANT CAPS LAB COAT SCRUBS COVERALL Gown General Surgery Tray Surgical Gown L2 and L3 surgical gowns Electrosurgical, Cutting Equipment Cover / Band Bag Dressing Wound Surgical Needle Tray surgical apparel Accessory

    Establishment Types

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