BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    ORFIT INDUSTRIES NV

    Reg #: 9613183 · FEI: 1000227792 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    87
    Establishment Types
    2
    Classifications
    16

    Registration Details

    Registration Name
    ORFIT INDUSTRIES NV
    Registration Number
    9613183
    FEI Number
    1000227792
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9A, VOSVELD
    City
    WIJNEGEM Antwerpen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K151946

    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
    Benzy 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
    Scissors, General, Surgical LRW
    Accelerator, Linear, Medical IYE
    System, Radiation Therapy, Charged-Particle, Medical LHN
    Warmer, Irrigation Solution LHC
    Twister, Brace Setting ITO
    Orthosis, Limb Brace IQI
    Orthosis, Moldable, Supportive, Skin Protective MNE
    Splint, Hand, And Components ILH
    Component, Cast LGF
    Table, Radiologic KXJ
    Splint, Nasal EPP
    Orthosis, Truncal/Orthosis, Limb MRI
    Surgical Table Cushion LWG
    Component, External, Limb, Ankle/Foot ISH
    Stirrup, External Brace Component ITC
    Orthosis, Lumbar IQE

    Proprietary Names

    Scissors Strong, Gingher shears , Bandage scissors , Sharp scissors , Cogged scissors Thermofit Orfit Aerial Couchtop Water bath Orfit Ease Orfizip Light NS Orfizip 43610 - Frameless SRS MASK SET CRANIAL (5 PCS.), 49660 - Frameless SRS MASK SET EXTENDED (5 PCS.) Isoforce HP PRO Positioning Device Preferred Black Preferred Orfit Flex COIL SPRING ORFITUBE Splint Padding and Lining Materials DYNASYST Orfit MRI-S Solution for Head & Neck Elekta Base Clamp Raycast Immobilization Systems The All-In-One Solution (AIO) - Belly- and Pelvic board U-Plast Orfilight Duon Bolus Orfit Natural Efficast SBRT - Stereotactic Body Radiation Therapy Immobilisation System Uon ORFIT® EXTREMITIES SOLUTION Allfit Orficast Thermoplastic Tape MRI solution for Philips, MRI-P solution for head and neck MRI solution for GE, MRI-G solution for head and neck The AIO Solution (The All In One Solution) Sagittilt The All-In-One Solution (AIO) - Prone Breast board The AIO Solution 3 The AIO Solution Orfiguard NoseFit Orfizip - Orfit Classic Hand Splints Integra Raycast MammoRx Carbon Fibre Breast Board HP SYSTEM PATIENT SUPPORT CUSHIONS 43453 - CRANIAL 4PI EXTENDED MASK (5 PCS.) 43450A - CRANIAL 4PI STEREOTACTIC MASK (5PCS.) 43450 - CRANIAL 4PI STEREOTACTIC MASK (5PCS.) 4352 - CRANIAL 4PI OPEN FACE MASK (5PCS.) 43451A - CRANIAL 4PI BASIC MASK (5 PCS.) 43451 - CRANIAL 4PI BASIC MASK (5 PCS.) 4352A - CRANIAL 4PI OPEN FACE MASK (5PCS.) Orfit Crystal NS Orfit Eco Black NS Orfitrans Excel Orfitrans Excel Black Orfit NS Orfit Colors NS Colorfit NS Orfibrace Orfitrans PETG Orfitrans Stiff Antibacterial Orfitrans Medium Soft Antibacterial Orfit Classic Orfitrans Medium Soft Beige Orfitrans Supra Soft Orfitrans Medium Soft Beige Antibacterial Orfitrans Extra Soft Beige Soft Fit NS Orfitrans Extra Soft Multifit NS Orfitrans Stiff Orfit Eco Orfitrans Extra Soft Silicone Omega Max Omega Black Omega Plus Prism Tecnofit Orfilight Black NS Aquafit NS Raycast High Precision Lung Board Solution Nanor Efficast/Nanor Hybrid The All-In-One Solution (AIO) - Breast- and Lung board MammoRx Proton Immobilization Solution

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)