Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613183

FEI Number

1000227792

Entity Name

ORFIT INDUSTRIES NV

City/State/Country

WIJNEGEM Antwerpen, BE

Establishment Address

9A, VOSVELD, WIJNEGEM Antwerpen B-2110, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ORFIT INDUSTRIES NV (Owner Number: 9015000)

Owner / Operator Contact Address

VOSVELD 9A, --, WIJNEGEM, BE-NOTA 2110, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162355

PMA Number

N/A

All Registered 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 Light NS Orfizip - Orfit Classic Hand Splints Integra Raycast MammoRx Carbon Fibre Breast Board

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-08-19
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2018-01-02
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	Class 2	892.5050	2020-04-10
LHC	Warmer, Irrigation Solution	Physical Medicine	Class 1	890.5950	2024-11-06
ITO	Twister, Brace Setting	Physical Medicine	Class 1	890.3410	2007-01-04
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1996-08-07
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2025-01-15
MNE	Orthosis, Moldable, Supportive, Skin Protective	Physical Medicine	Class 1	890.3475	2021-05-28
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2018-01-02
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	1997-05-06
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-02-07
LGF	Component, Cast	Orthopedic	Class 1	888.5940	1996-08-07
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2005-07-11
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2015-01-20
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2020-08-17
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2019-08-07
EPP	Splint, Nasal	Ear, Nose, Throat	Class 1	874.5800	2022-05-03
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	1997-05-06
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2012-01-17
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2018-01-02

Official Correspondent

No official correspondent registered.

US Agent Details

Benzy Arazy Business: Medes USA C/O Matan Arazy Email: Medes@Arazygroup.com Phone: (415) 9921126

Related Public Records

Same Entity

ORFIT INDUSTRIES NV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

Similar Registrations

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8043496	REDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
8040373	NADEEM SURGICAL CORP. PRIVATE LTD.	SIALKOT Punjab, PK
2531475	URAMIX, INC.	E Lansdowne, PA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613183. Last updated year: 2026. Please use registration number 9613183 when referencing this establishment in official correspondence.