BEUDAMED
    FDA Registration Active 🇨🇳 China

    Ureteral Access Sheaths (IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250)

    Reg #: 3038296436 · FEI: 3038296436 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ETERNAL (SHANGHAI) MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3038296436
    FEI Number
    3038296436
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 1, 9 Huiye Road, Chedun Town, Songjiang District
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K243820

    Owner / Operator

    Firm Name
    Eternal (Shanghai) Medical Technology Co., Ltd.
    Operator Number
    10093239
    Address
    Building 1, 9 Huiye Road, Chedun Town, Songjiang District
    City
    Shanghai
    State
    CN-NOTA
    Postal Code
    201611
    Country
    CN
    Correspondent
    Qing Sun

    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
    Endoscopic Access Overtube, Gastroenterology-Urology FED

    Proprietary Names

    Ureteral Access Sheaths (IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)