BEUDAMED
    FDA Registration Active 🇨🇳 China

    EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV

    Reg #: 3013443304 · FEI: 3013443304 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    EXACT MEDICAL MANUFACTURING, INC.
    Registration Number
    3013443304
    FEI Number
    3013443304
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    21# Qingjiang Road
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K120045

    Owner / Operator

    Firm Name
    Exact Medical Manufacturing, Inc.
    Operator Number
    10053949
    Address
    21# Qingjiang Road
    City
    Changzhou
    State
    Jiangsu
    Postal Code
    213022
    Country
    CN
    Correspondent
    Ryan Power

    US Agent

    Business Name
    Exact Medical Manufacturing, Inc.
    Contact Name
    Ryan Power
    Address
    4917 William St Ste C
    City
    Lancaster
    State
    NY
    ZIP
    14086
    Country
    US
    Email
    [email protected]
    Phone
    716 6810076

    Products

    Device Name Product Code
    Gown, Surgical FYA

    Proprietary Names

    EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device