BEUDAMED
    FDA Registration Active 🇨🇳 China

    Latex Foley catheters, Silicone Foley catheters

    Reg #: 3014637079 · FEI: 3014637079 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Hangzhou Primecare Medical Co.,Ltd.
    Registration Number
    3014637079
    FEI Number
    3014637079
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 408-409, Zancheng Center West, Shangcheng District, 310008 Hangzhou, PEOPLE'S REPUBLIC OF CHINA
    City
    hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K082815

    Owner / Operator

    Firm Name
    Hangzhou Primecare Medical Co.Ltd
    Operator Number
    10058286
    Address
    Room 408-409, Zancheng Center west, Shangcheng District, 310008 Hangzhou, PEOPLE'S REPUBLIC OF CHINA
    City
    hangzhou
    State
    Zhejiang
    Postal Code
    310008
    Country
    CN
    Correspondent
    Juanjuan Zhang

    US Agent

    Business Name
    3dstocking Inc
    Contact Name
    Wei ZHANG
    Address
    3 Germay Dr Ste 5 Pmb 29339
    City
    Wilmington
    State
    DE
    ZIP
    19804
    Country
    US
    Email
    [email protected]
    Phone
    772 9996108

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    Latex Foley catheters, Silicone Foley catheters

    Establishment Types

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