BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    WEAR TEX S. DE R.L. DE C.V.

    Reg #: 3013410562 · FEI: 3013410562 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    23
    Establishment Types
    3
    Classifications
    24

    Registration Details

    Registration Name
    WEAR TEX S. DE R.L. DE C.V.
    Registration Number
    3013410562
    FEI Number
    3013410562
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    312 Hilatura
    City
    Torreon Coahuila
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K101705

    Owner / Operator

    Firm Name
    Wear Tex S. de R.L. de C.V.
    Operator Number
    10052848
    Address
    312 Hilatura
    City
    Torreon
    State
    Coahuila
    Postal Code
    27272
    Country
    MX
    Correspondent
    Jessica L Lester

    US Agent

    Business Name
    Encompass Group, LLC
    Contact Name
    Jessica Lester
    Address
    615 Macon St
    City
    Mcdonough
    State
    GA
    ZIP
    30253
    Country
    US
    Email
    [email protected]
    Phone
    770 6262172

    Products

    Device Name Product Code
    Gown, Examination FME
    Accessory, Surgical Apparel LYU
    Bandage, Cast ITG
    Fiber, Medical, Absorbent FRL
    Sheet, Burn FPY
    Bandage, Elastic FQM
    System, Thermal Regulating DWJ
    Instrument, Surgical, Disposable KDC
    Cap, Surgical FYF
    Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
    Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection QPC
    Drape, Surgical, Exempt PUI
    Garment, Protective, For Incontinence EYQ
    Drape, Adhesive, Aerosol KGT
    Table, Operating-Room, Pneumatic FWW
    Bedding, Disposable, Medical KME
    Protector, Skin Pressure FMP
    Wrap, Sterilization FRG
    Non-Surgical Gown OEA
    Drape, Surgical, Antimicrobial KKX
    Component, Cast LGF
    Device, Transfer, Patient, Manual FMR
    Gown, Surgical FYA
    Stocking, Medical Support (For General Medical Purposes) FQL

    Proprietary Names

    TECHStyles Stockinette X-Span Cotton Stockinette Care-Nett Essential C.A.R.E. Ultra C.A.R.E. Anti-Embolism Stocking (C.A.R.E. brands) Albahealth Guardian compression sleeve LIFESPAN C.A.R.E Span Encompass Group, LLC Guardian Incontinent brief Guardian Hip Panty Guardian Joint Garment Guardian Hip Protector Guardian heel & Elbow Sleeve Guardian Spandex Sleeve Guardian Heel & Elbow Protector Albahealth Impervious Stockinette Alba Sterile Stockinette Medical Compression Stocking (C.A.R.E. brands) Medical Support Stocking (C.A.R.E. brands)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device