BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    43451 - CRANIAL 4PI BASIC MASK (5 PCS.)

    Reg #: 9613183 · FEI: 1000227792 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORFIT INDUSTRIES NV
    Registration Number
    9613183
    FEI Number
    1000227792
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9A, VOSVELD
    City
    WIJNEGEM Antwerpen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K202050

    Owner / Operator

    Firm Name
    ORFIT INDUSTRIES NV
    Operator Number
    9015000
    Address
    VOSVELD 9A, --
    City
    WIJNEGEM
    State
    BE-NOTA
    Postal Code
    2110
    Country
    BE

    US Agent

    Business Name
    Medes USA C/O Matan Arazy
    Contact Name
    Benny Arazy
    Address
    15201 6th Ave NE, ,
    City
    Shoreline
    State
    WA
    ZIP
    98155
    Country
    US
    Email
    [email protected]
    Phone
    415 9921126

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    43451 - CRANIAL 4PI BASIC MASK (5 PCS.) 43453 - CRANIAL 4PI EXTENDED MASK (5 PCS.) 43450A - CRANIAL 4PI STEREOTACTIC MASK (5PCS.) 4352 - CRANIAL 4PI OPEN FACE MASK (5PCS.) 4352A - CRANIAL 4PI OPEN FACE MASK (5PCS.) 43450 - CRANIAL 4PI STEREOTACTIC MASK (5PCS.) 43451A - CRANIAL 4PI BASIC MASK (5 PCS.)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)