BEUDAMED
    FDA Registration Active 🇨🇳 China

    Disposable Isolation Gowns (S, M, L, XL, XXL, XXXL)

    Reg #: 3016680688 · FEI: 3016680688 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO.,LTD
    Registration Number
    3016680688
    FEI Number
    3016680688
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 1 & No.3 Building, No.6, Ji'an Road, Tong'an District
    City
    Xiamen Fujian
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223411

    Owner / Operator

    Firm Name
    XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO.,LTD
    Operator Number
    10062942
    Address
    No.1 & No.3 Building, No.6, Jia'n Road, Tong'an District
    City
    Xiamen
    State
    Fujian
    Postal Code
    361100
    Country
    CN
    Correspondent
    Jianli Kang

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Gown, Isolation, Surgical FYC

    Proprietary Names

    Disposable Isolation Gowns (S, M, L, XL, XXL, XXXL)

    Establishment Types

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