BEUDAMED
    FDA Registration Active 🇨🇳 China

    ComfortGuard Plus Surgical Gown, I500, ComfortGuard Surgical Gown, I500

    Reg #: 3004911384 · FEI: 3004911384 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.
    Registration Number
    3004911384
    FEI Number
    3004911384
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1805 HONGGAO ROAD, Xiuzhou Industry Zone
    City
    JIAXING Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K162442

    Owner / Operator

    Firm Name
    Alleset, Inc.
    Operator Number
    10040018
    Address
    4142 INDUSTRy Way
    City
    Flowery Branch
    State
    GA
    Postal Code
    30542
    Country
    US

    Products

    Device Name Product Code
    Gown, Surgical FYA

    Proprietary Names

    ComfortGuard Plus Surgical Gown, I500, ComfortGuard Surgical Gown, I500

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device