BEUDAMED
    FDA Registration Active 🇨🇳 China

    Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)

    Reg #: 3004158259 · FEI: 3004158259 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Hubei Haixin Protective Products Group Co.,Ltd
    Registration Number
    3004158259
    FEI Number
    3004158259
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Jinsong Avenue 8-8,Chengdong Industrial Zone
    City
    Songzi City Hubei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K222266

    Owner / Operator

    Firm Name
    Hubei Haixin Protective Products Group Co.,Ltd
    Operator Number
    9058446
    Address
    Jinsong Avenue 8-8,Chengdong Industrial Zone
    City
    Songzi
    State
    Hubei
    Postal Code
    434205
    Country
    CN
    Correspondent
    Eric Yang

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Mask, Surgical FXX

    Proprietary Names

    Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device