BEUDAMED
    FDA Registration Active 🇺🇸 United States

    New York Embroidery Studio

    Reg #: 3007088677 · FEI: 3007088677 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    New York Embroidery Studio
    Registration Number
    3007088677
    FEI Number
    3007088677
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    140 58th St., Building A, Suite 8N
    City
    Brooklyn
    State
    NY
    ZIP
    11220
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202697

    Owner / Operator

    Firm Name
    NEW YORK EMBROIDERY STUDIO
    Operator Number
    10073842
    Address
    307 West 36th Street, 3rd Floor
    City
    New York City
    State
    NY
    Postal Code
    10018
    Country
    US
    Correspondent
    MICHELLE FEINBERG

    Products

    Device Name Product Code
    Mask, Surgical FXX
    Gown, Surgical FYA
    Non-Surgical Gown OEA

    Proprietary Names

    SafeSource Direct Surgical Mask with Ties - Level 3 SafeSource Direct Surgical Mask with Ties - Level 1 SafeSource Direct Procedure Mask with Ear Loops - Level 3 SafeSource Direct Procedure Mask with Ear Loops - Level 1 Non-Reinforced Surgical Gown, L4 Poly-Reinforced Surgical Gown, L4 Surgical Face Mask (ASTM Level 3) Trinity Disposable Isolation Gown Non-Surgical Gown - E52 Isolation Gown Standard Surgical Gown

    Establishment Types

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