BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHANGHAI MICROPORT EP MEDTECH CO., LTD.

    Reg #: 3009393076 · FEI: 3009393076 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SHANGHAI MICROPORT EP MEDTECH CO., LTD.
    Registration Number
    3009393076
    FEI Number
    3009393076
    Status
    Active
    Expiry Year
    2026
    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
    Trocar DRC
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF

    Proprietary Names

    PathBuilder Steerable Introducer PathBuilder Transseptal Guiding Introducer PathBuilder Transseptal Needle EasyFinder™ Fixed Curve Diagnostic Catheter FORLNK™ Cable for Mapping Catheter

    Establishment Types

    Manufacture Medical Device