BEUDAMED
    FDA Registration Active 🇨🇳 China

    RFX+CARE MANUFACTURING CO., LTD.

    Reg #: 3007307589 · FEI: 3007307589 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    40
    Establishment Types
    3
    Classifications
    21

    Registration Details

    Registration Name
    RFX+CARE MANUFACTURING CO., LTD.
    Registration Number
    3007307589
    FEI Number
    3007307589
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.599-1F Wuxie Road, Yuecheng District
    City
    Shaoxing Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K083817

    Owner / Operator

    Firm Name
    RFX+CARE Manufacturing Co., Ltd.
    Operator Number
    10027255
    Address
    No.599-1F Wuxie Road, Yuecheng District
    City
    Shaoxing
    State
    Zhejiang
    Postal Code
    312000
    Country
    CN

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Dressing, Wound, Occlusive NAD
    Condom HIS
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Vinyl Patient Examination Glove LYZ
    Tape And Bandage, Adhesive KGX
    Burn Kit With Drug OJI
    Bedding, Disposable, Medical KME
    Pack, Hot Or Cold, Disposable IMD
    First Aid Kit With Drug LRR
    Toothbrush, Manual EFW
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Strip, Temperature, Forehead, Liquid Crystal KPD
    Mask, Surgical FXX
    Bandage, Elastic FQM
    Strip, Adhesive, Closure, Skin FPX
    Dressing, Wound, Hydrophilic NAC
    Pack, Hot Or Cold, Reusable IME
    First Aid Kit Without Drug OHO
    Sling, Arm ILI
    Retractor GAD
    Gauze / Sponge,Nonresorbable For External Use NAB

    Proprietary Names

    Hydrocolloid Dressing After Bites Blister Plaster Spot Patch Acne Patch Insect Bites Patch Pimple Patch Blemish Patch m. Dior Face mask Vinyl Patient Examination Glove-Disposable Gloves Disposable Gloves Vinyl Patient Examination Gloves Examination Gloves RFX+CARE Plaster, adhesive tape Barbie Collection Water-Proof Adhesive Bandages Set Bee plaster Burn kit Emergency blanket Body warmer Ice pack Toothbrush Burn gel dressing Burn gel Forehead thermometer surgical face mask Elastic bandage Skin closure strip Sterile wound compress Dry swab Hot/cold compress Cold /Hot pack VITRONIC BOSS First Aid Kit Triangular bandage Tick remover Wound dressing Sterile Wound bandage

    Establishment Types

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