BEUDAMED
    FDA Registration Active 🇨🇳 China

    PEEK Spinal Fusion Cage

    Reg #: 3026311512 · FEI: 3026311512 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
    Registration Number
    3026311512
    FEI Number
    3026311512
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO.12 Jinfeng Road, West Taihu Science and Technology Industrial Park
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223776

    Owner / Operator

    Firm Name
    Changzhou Geasure Medical Apparatus and Instruments Co., Ltd
    Operator Number
    10086983
    Address
    No. 12, Jinfeng Road, West Taihu Science and Technology Industrial Park
    City
    Changzhou
    State
    Jiangsu
    Postal Code
    213149
    Country
    CN
    Correspondent
    Jing Huang

    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
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    PEEK Spinal Fusion Cage

    Establishment Types

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