BEUDAMED
    FDA Registration Active 🇨🇳 China

    BANDEX INDUSTRIAL CORP.

    Reg #: 3007327603 · FEI: 3007327603 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    12
    Establishment Types
    4
    Classifications
    14

    Registration Details

    Registration Name
    BANDEX INDUSTRIAL CORP.
    Registration Number
    3007327603
    FEI Number
    3007327603
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.1, Chuangye West Road, Shuanglinpianqu, Liangang Industrial Park, Jinwan District
    City
    Zhuhai City Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K170136

    Owner / Operator

    Firm Name
    Bandex Industrial Corp.
    Operator Number
    10027300
    Address
    No.1,Chuangye West Road, Shuanglinpianqu, Liangang Industrial Park,Jinwan District
    City
    Zhuhai City
    State
    Guangdong
    Postal Code
    519045
    Country
    CN
    Correspondent
    C. C Chen

    US Agent

    Business Name
    Fleet Link, Inc
    Contact Name
    Ingrid Liao
    Address
    83 Hale St
    City
    Bridgewater
    State
    MA
    ZIP
    02324
    Country
    US
    Email
    [email protected]
    Phone
    508 2791500 ext. 121

    Products

    Device Name Product Code
    Dressing, Wound, Occlusive NAD
    Pick, Massaging JET
    Tape And Bandage, Adhesive KGX
    Polymer Patient Examination Glove LZA
    Medical Glove, Specialty LZC
    Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile NOB
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Bandage, Elastic FQM
    Applicator, Absorbent Tipped, Sterile KXG
    Knife, Orthopedic HTS
    Toothbrush, Manual EFW
    Pad, Eye HMP
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Gauze / Sponge,Nonresorbable For External Use NAB

    Proprietary Names

    Dressing, wound, occlusive pick, massaging Tape and bandage, adhesive Nitrile Gloves UNIT, ULTRAVIOLET SANITATION/STERILIZATION (FOR TOOTHBRUSHES), NON-STERILE Cotton applicators BANDAGE, ELASTIC Nitrile Gloves, Scissors TOOTHBRUSH, MANUAL PAD, EYE Face mask per enforcement policy for face masks and respirators during the declared public health emergency Gauze / sponge,nonresorbable for external use

    Establishment Types

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