BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ALFA GATE - MAZEN LTD.

    Reg #: 3013701115 · FEI: 3013701115 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    ALFA GATE - MAZEN LTD.
    Registration Number
    3013701115
    FEI Number
    3013701115
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    hitin st2
    City
    kfar qara Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K072917

    Owner / Operator

    Firm Name
    alfa gate - mazen ltd.
    Operator Number
    10058549
    Address
    hitin st2
    City
    kfar qara
    State
    Northern
    Postal Code
    3007500
    Country
    IL
    Correspondent
    mohamad zahalka

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Implant, Endosseous, Orthodontic OAT
    Abutment, Implant, Dental, Endosseous NHA
    Drill, Dental, Intraoral DZA

    Proprietary Names

    Alfa Gate

    Establishment Types

    Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Repack or Relabel Medical Device