BEUDAMED
    FDA Registration Active 🇨🇳 China

    Pulmo-Protect™ lung function filter

    Reg #: 3015168843 · FEI: 3015168843 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INTERSURGICAL MEDICAL APPARATUS (CHANGZHOU) CO., LTD.
    Registration Number
    3015168843
    FEI Number
    3015168843
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 1011, Liaohe Road, Xinbei District
    City
    Changzhou City Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K013123

    Owner / Operator

    Firm Name
    Intersurgical Medical Apparatus (Changzhou) Co., Ltd.
    Operator Number
    10059558
    Address
    No. 1011, Liaohe Road, Xinbei District
    City
    Changzhou City
    State
    Jiangsu
    Postal Code
    213125
    Country
    CN
    Correspondent
    Ivan Seniut

    US Agent

    Business Name
    Intersurgical Inc
    Contact Name
    Kerrie Campbell
    Address
    5010 Campuswood Dr, Ste 102
    City
    East Syracuse
    State
    NY
    ZIP
    13057
    Country
    US
    Email
    [email protected]
    Phone
    315 4512900 ext. 500

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG

    Proprietary Names

    Pulmo-Protect™ lung function filter 1691000, 1691001, 1691002, 1691003, 1691004, 1691005, 1691006, 1691007, 1691050, 1691051, 1691052, 1691053, 1691010 1691011, 1691012, 1691016, 1691013, 1691014, 1691009

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)