BEUDAMED
    FDA Registration Active 🇨🇳 China

    Makrite Hubei Industrial Co., Ltd.

    Reg #: 3017168988 · FEI: 3017168988 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Makrite Hubei Industrial Co., Ltd.
    Registration Number
    3017168988
    FEI Number
    3017168988
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 1, Zhonger Street, Guang Gu Industrial Park
    City
    Chibi High-Tech Zone Hubei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K895077

    Owner / Operator

    Firm Name
    Makrite Industries Inc.
    Operator Number
    8043227
    Address
    11F-5., No.79, Sec.1, Xintai 5th Rd., Xizhi Dist.,
    City
    New Taipei City
    State
    TW-NWT
    Postal Code
    221
    Country
    TW
    Correspondent
    Cynthia Shih

    US Agent

    Business Name
    Makrite North America
    Contact Name
    Legrand Lindor
    Address
    12 Breck St
    City
    Milton
    State
    MA
    ZIP
    02186
    Country
    US
    Email
    [email protected]
    Phone
    855 5648398

    Products

    Device Name Product Code
    Mask, Surgical FXX
    Respirator, Surgical MSH
    Accessory, Surgical Apparel LYU

    Proprietary Names

    Halyard FIT+4803, 9603, 9603S Makrite Grainger International Inc. AKA Grainger Global Sourcing HEALTHCARE RESPIRAT HEALCARE RESPIRATO Disposable Medical Face Mask (M643BE) Disposable Surgical Face Mask (M663BE, M663BT) Medline Face Mask Ear Loop Mask

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)