BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Medical Eye Disposable Shield

    Reg #: 3006582165 · FEI: 3006582165 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    5
    Classifications
    1

    Registration Details

    Registration Name
    MANUFACTURAS KE
    Registration Number
    3006582165
    FEI Number
    3006582165
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Alejandro Perez Rocha, 82
    City
    Nogales Sonora
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K875302

    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
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY

    Proprietary Names

    Medical Eye Disposable Shield

    Establishment Types

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