BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TWO ONE TWO NEW YORK, INC.

    Reg #: 3013269506 · FEI: 3013269506 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    TWO ONE TWO NEW YORK, INC.
    Registration Number
    3013269506
    FEI Number
    3013269506
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    60 Heartland Blvd
    City
    Edgewood
    State
    NY
    ZIP
    11717
    Country
    US

    Owner / Operator

    Firm Name
    Two One Two New York, Inc.
    Operator Number
    10077084
    Address
    60 Heartland Blvd
    City
    Edgewood
    State
    NY
    Postal Code
    11717
    Country
    US
    Correspondent
    Christina Fumei

    Products

    Device Name Product Code
    Dress, Surgical FYE
    Cap, Surgical FYF
    Non-Surgical Gown OEA
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Cover, Shoe, Operating-Room FXP
    Apron, Protective IWO

    Proprietary Names

    DISPOSABLE SURGICAL GOWN AAMI LEVEL 2 NON-STERILE DISPOSABLE BOUFFANT CAP TRIPLE LAYER SMS SINGLE LAYER SMS BOUFFANT CAP-DISPOSABLE DISPOSABLE BOUFFANT CAP SINGLE LAYER SMS TRIPLE LAYER SMS BOUFFANT CAP-DISPOSABLE DISPOSABLE BOUFFANT HEADCOVER ANSI/AAMI REUSABLE ISOLATION GOWN LEVEL 1 ANSI/AAMI IIJA COMPLIANT DISPOSABLE ISOLATION GOWN LEVEL 2 ANSI/AAMI DISPOSABLE ISOLATION GOWN LEVEL 3 ANSI/AAMI DISPOSABLE AAMI ISOLATION GOWN LEVEL 3 LEVEL 2 DISPOSABLE ISOLATION GOWN MODEL 27000L DISPOSABLE ISOLATION GOWN ANSI/AAMI LEVEL 2 LEVEL 2 DISPOSABLE ISOLATION GOWN MODEL 27000XL DISPOSABLE ISOLATION GOWN LEVEL 1 ANSI/AAMI DISPOSABLE BARRIER FACE COVERING LEVEL 1 ANSI/AAMI REUSABLE BARRIER FACE COVERING ASTM 3502 DISPOSABLE BARRIER FACE COVERING LEVEL 2 ANSI/AAMI DISPOSABLE BOOTIES-SHOE COVER ANSI/AAMI DISPOSABLE SHOE COVER DISPOSABLE SLEEVE COVERING ANSI/AAMI DISPOSABLE PE COATED SMS SLEEVE PROTECTOR DISPOSABLE APRON ANSI/AAMI

    Establishment Types

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