BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BAYLAB USA

    Reg #: 3017517827 · FEI: 3017517827 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    BAYLAB USA
    Registration Number
    3017517827
    FEI Number
    3017517827
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2230 LBJ FREEWAY, Suite 100
    City
    Dallas
    State
    TX
    ZIP
    75234
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212302

    Owner / Operator

    Firm Name
    BayLab USA
    Operator Number
    10078379
    Address
    2230 LBJ FREEWAY, Suite 100
    City
    Dallas
    State
    TX
    Postal Code
    75234
    Country
    US
    Correspondent
    Ashley Park

    Products

    Device Name Product Code
    Mask, Surgical FXX
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Mask, Surgical, Eua Authorized QMF

    Proprietary Names

    BAYLAB USA Surgical Mask BL3-59941 BLK-39425 BLW-64926 BL3-50221

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device