BEUDAMED
    FDA Registration Active 🇨🇳 China

    Gowns, surgical; AAMI Lever 3 Protection Gowns for surgeon

    Reg #: 3018058145 · FEI: 3018058145 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    EXCELLENT MEDICAL TECHNOLOGY GROUP CO., LTD.
    Registration Number
    3018058145
    FEI Number
    3018058145
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room# 2301, Decheng Jiayuan Plaza, No. 1539 Xiangcheng Road,, Xiangcheng District
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K220665

    Owner / Operator

    Firm Name
    Excellent Medical Technology Group Co., Ltd.
    Operator Number
    10082410
    Address
    Room# 2301, Decheng Jiayuan Plaza, No. 1539 Xiangcheng Road,, Xiangcheng District
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215131
    Country
    CN
    Correspondent
    Kenney SONG

    US Agent

    Business Name
    Beyond Compliance manufacturing LLC
    Contact Name
    Zheng XU
    Address
    4070 Blue Heron Dr, Auburn Hill
    City
    Gowen
    State
    MI
    ZIP
    49326
    Country
    US
    Email
    [email protected]
    Phone
    248 5508758

    Products

    Device Name Product Code
    Gown, Surgical FYA

    Proprietary Names

    Gowns, surgical; AAMI Lever 3 Protection Gowns for surgeon

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility