BEUDAMED
    FDA Registration Active 🇨🇳 China

    Balloon Inflation System

    Reg #: 3027518990 · FEI: 3027518990 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NINGBO HICREN BIOTECHNOLOGY CO., LTD.
    Registration Number
    3027518990
    FEI Number
    3027518990
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 1 Block B No.777 Binhai 4th Road Hangzhou Bay New District
    City
    Ningbo Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232842

    Owner / Operator

    Firm Name
    Ningbo HicRen Biotechnology Co., Ltd.
    Operator Number
    10088059
    Address
    Building 1 Block B No.777 Binhai 4th Road Hangzhou Bay New District
    City
    Ningbo
    State
    Zhejiang
    Postal Code
    315336
    Country
    CN
    Correspondent
    Jia Qian

    US Agent

    Business Name
    PUREVISION AI, INC.
    Contact Name
    DJ Fang
    Address
    111 Town Square Place, Suite 1203
    City
    Jersey City
    State
    NJ
    ZIP
    07310
    Country
    US
    Email
    [email protected]
    Phone
    201 5035758

    Products

    Device Name Product Code
    Cement, Bone, Vertebroplasty NDN

    Proprietary Names

    Balloon Inflation System

    Establishment Types

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