BEUDAMED
    FDA Registration Active 🇨🇳 China

    PathBuilder Steerable Introducer

    Reg #: 3009393076 · FEI: 3009393076 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHANGHAI MICROPORT EP MEDTECH CO., LTD.
    Registration Number
    3009393076
    FEI Number
    3009393076
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 23&26&28, Lane 588, Tianxiong Rd.
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K211530

    Owner / Operator

    Firm Name
    Shanghai MicroPort EP MedTech Co., Ltd.
    Operator Number
    10085214
    Address
    Building 23&26&28, Lane 588, Tianxiong Rd.
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201318
    Country
    CN
    Correspondent
    Di Wu

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    PathBuilder Steerable Introducer

    Establishment Types

    Manufacture Medical Device