BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    MANUFACTURAS KE

    Reg #: 3006582165 · FEI: 3006582165 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    21
    Establishment Types
    5
    Classifications
    7

    Registration Details

    Registration Name
    MANUFACTURAS KE
    Registration Number
    3006582165
    FEI Number
    3006582165
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Alejandro Perez Rocha, 82
    City
    Nogales Sonora
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K890128

    Owner / Operator

    Firm Name
    Manufacturas KE
    Operator Number
    10032451
    Address
    Alejandro Perez Rocha, 82
    City
    Nogales
    State
    Sonora
    Postal Code
    84094
    Country
    MX
    Correspondent
    Francisco J Rivera

    US Agent

    Business Name
    Alpha ProTech Inc
    Contact Name
    Beatriz O'Daly
    Address
    1600 W La Quinta Rd Ste 1
    City
    Nogales
    State
    AZ
    ZIP
    85621
    Country
    US
    Email
    [email protected]
    Phone
    520 8600060

    Products

    Device Name Product Code
    Mask, Surgical FXX
    Gown, Examination FME
    Cover, Shoe, Operating-Room FXP
    Shoe And Shoe Cover, Conductive BWP
    Accessory, Surgical Apparel LYU
    Cap, Surgical FYF
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY

    Proprietary Names

    Disposable Surgical Face Mask Coverall Shields Gown Examination SafeStep AquaTrak MaxGrip UltraGrip SureGrip Aprons Lab Coats Frocks Scrub Wear Gowns Sleeve Protectors Coveralls Hoods Bouffant Caps Beard Covers Combo-Shield Medical Eye Disposable Shield Add-A-Shield

    Establishment Types

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