BEUDAMED
    FDA Registration Active 🇨🇳 China

    Ranir Changshu Oral Care CO., Ltd

    Reg #: 3007336881 · FEI: 3007336881 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    13
    Establishment Types
    3
    Classifications
    5

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    Registration Details

    Registration Name
    Ranir Changshu Oral Care CO., Ltd
    Registration Number
    3007336881
    FEI Number
    3007336881
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building 2, Export Processing Zone, Wangwan North Road, CEDZ
    City
    Changshu Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K091175

    Owner / Operator

    Firm Name
    RANIR LLC
    Operator Number
    1825660
    Address
    515 Eastern Ave., --
    City
    Allegan
    State
    MI
    Postal Code
    49010
    Country
    US
    Correspondent
    Tricia Pasek

    Products

    Device Name Product Code
    Wax, Dental, Intraoral EGD
    Toothbrush, Manual EFW
    Toothbrush, Powered JEQ
    Mouthguard, Over-The-Counter OBR
    Floss, Dental JES

    Proprietary Names

    POWERED TOOTHBRUSH 3G 1G SmileSonic Total Power Advance Clean EasyFlex Polaris Kids Infinity Plackers Essential Clean USB Grind-No-More

    Establishment Types

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