Orfit Industries N V

FDA Filings

This page includes the latest FDA filings for Orfit Industries N V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005518451
• FEI Number: 3005518451
• Name: ORFIT INDUSTRIES AMERICA
• Owner & Operator: ORFIT INDUSTRIES NV
• Contact Address: VOSVELD 9A --; WIJNEGEM BE-NOTA 2110 BE
• Official Correspondent:
  • EDDY - MARIVOET
  • 32-03-3262026-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 810 Ford Drive ; Norfolk, VA 23523 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 9613183
• FEI Number: 1000227792
• Name: Benny Arazy
• Owner & Operator: ORFIT INDUSTRIES NV
• Contact Address: VOSVELD 9A --; WIJNEGEM BE-NOTA 2110 BE
• Official Correspondent:
  • EDDY - MARIVOET
  • 32-03-3262026-x
• US Agent:
  • Benny Arazy
  • Medes USA Inc.
  • 415 8024021 0
  • 206 6816822
  • medes@arazygroup.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 701 5th Ave, Suite 4200, ; Seattle, WA 98104 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 05420028706268 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028706220 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028706206 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028706190 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028706183 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705902 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705889 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705841 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705711 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705704 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705681 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705612 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705605 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705384 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705278 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705223 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705179 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705018 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028705001 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704998 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704981 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704882 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704875 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704844 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704820 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704806 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704783 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704776 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704769 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704684 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704677 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704349 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704295 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028704288 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703915 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703885 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703861 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703854 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703847 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703830 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703823 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703816 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703809 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703793 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703786 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703779 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703762 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703755 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703731 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703717 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703700 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703557 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703120 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703113 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028703014 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702994 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702987 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702970 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702956 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702895 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702833 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702772 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702529 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702192 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702109 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702079 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702024 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028702017 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701997 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701980 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701966 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701874 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701867 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701768 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701409 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701331 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701324 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701317 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701300 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028701294 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700846 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700792 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700570 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700525 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700518 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700501 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700464 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700457 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700433 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700419 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700396 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700365 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700358 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700327 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700310 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700297 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700273 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700105 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700099 Orfit Industries NV	Orfit Industries	2022-12-15
GUDID 05420028700020 Orfit Industries NV	Orfit Industries	2022-12-15
PMN K202068 Orfit Industries NV	The AIO Solution 3.0	2020-08-14
PMN K200282 | LHN Benny Arazy [ORFIT INDUSTRIES NV]	Orfit Aerial Couchtop	2020-04-10
PMN K200282 Orfit Industries NV	Orfit Aerial Couchtop	2020-04-08
PMN K191158 | IYE ORFIT INDUSTRIES AMERICA [ORFIT INDUSTRIES NV]	The AIO Solution	2019-08-07
PMN K191158 Orfit Industries NV	The AIO Solution	2019-08-06
PMN K171734 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	HP PRO Positioning Device	2018-01-02
PMN K162862 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Raycast High Precision Lung Board Solution	2018-01-02
PMN K162355 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Raycast MammoRx Carbon Fibre Breast Board	2018-01-02
PMN K151946 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Thermofit	2018-01-02
PMN K171734 Orfit Industries NV	HP PRO Positioning Device	2017-07-25
PMN K162355 Orfit Industries NV	Raycast MammoRx Carbon Fibre Breast Board	2016-11-22
PMN K162862 Orfit Industries NV	Raycast High Precision Lung Board Solution	2016-11-09
PMN K151207 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Proton Immobilization Solution	2015-08-19
LRW Benny Arazy [ORFIT INDUSTRIES NV]	Scissors Cogged - Scissors Strong	2015-08-19
PMN K151207 ORFIT INDUSTRIES NV	Proton Immobilization Solution	2015-07-28
PMN K141787 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	The All-In-One Solution (AIO) - Prone Breast board	2015-01-20
PMN K141787 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Sagittilt	2015-01-20
PMN K131795 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Nanor	2015-01-20
PMN K131795 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Efficast/Nanor Hybrid	2015-01-20
PMN K141787 ORFIT INDUSTRIES NV	SAGITTILT	2014-08-07
PMN K131795 ORFIT INDUSTRIES NV	NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS	2013-09-26
PMN K930246 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	The All-In-One Solution (AIO) - Breast- and Lung board	2012-01-17
PMN K930246 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	MammoRx	2012-01-17
PMN K050888 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Integra	2012-01-17
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Uon	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	U-Plast	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	The All-In-One Solution (AIO) - Belly- and Pelvic board	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	SBRT - Stereotactic Body Radiation Therapy Immobilisation System	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Raycast Immobilization Systems	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Orfit Natural	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Orfit MRI-S Solution for Head & Neck	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Orfilight	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	ORFIT? EXTREMITIES SOLUTION	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Elekta Base Clamp	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Efficast	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Duon	2008-02-07
PMN K991319 | IYE Benny Arazy [ORFIT INDUSTRIES NV]	Bolus	2008-02-07
ITO Benny Arazy [ORFIT INDUSTRIES NV]	Orfit Ease	2007-01-04
KXJ Benny Arazy [ORFIT INDUSTRIES NV]	The AIO Solution (The All In One Solution)	2005-07-11
KXJ Benny Arazy [ORFIT INDUSTRIES NV]	MRI solution for Philips, MRI-P solution for head and neck	2005-07-11
KXJ Benny Arazy [ORFIT INDUSTRIES NV]	MRI solution for GE, MRI-G solution for head and neck	2005-07-11
LWG Benny Arazy [ORFIT INDUSTRIES NV]	HP SYSTEM PATIENT SUPPORT CUSHIONS	2003-09-05
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Soft Fit NS	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Preferred	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Preferred Black	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans Supra Soft	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans Stiff	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans Stiff Antibacterial	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans PETG	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans Medium Soft Beige	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans Medium Soft Beige Antibacterial	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans Medium Soft Antibacterial	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans Extra Soft	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans Extra Soft Silicone	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans Extra Soft Beige	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans Excel	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfitrans Excel Black	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfit NS	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfit Eco	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfit Eco Black NS	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfit Crystal NS	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfit Colors NS	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfit Classic	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Orfibrace	2000-01-10
ISH Benny Arazy [ORFIT INDUSTRIES NV]	Colorfit NS	2000-01-10
MRI Benny Arazy [ORFIT INDUSTRIES NV]	Orfizip Light NS	1997-05-06
MRI Benny Arazy [ORFIT INDUSTRIES NV]	Orfizip - Orfit Classic Hand Splints	1997-05-06
ILH Benny Arazy [ORFIT INDUSTRIES NV]	Preferred	1997-05-06
ILH Benny Arazy [ORFIT INDUSTRIES NV]	Preferred Black	1997-05-06
ILH Benny Arazy [ORFIT INDUSTRIES NV]	Orfit Flex	1997-05-06
ILH Benny Arazy [ORFIT INDUSTRIES NV]	ORFITUBE	1997-05-06
ILH Benny Arazy [ORFIT INDUSTRIES NV]	DYNASYST	1997-05-06
ILH Benny Arazy [ORFIT INDUSTRIES NV]	COIL SPRING	1997-05-06
IQE Benny Arazy [ORFIT INDUSTRIES NV]	Orfizip	1996-08-20
IQE Benny Arazy [ORFIT INDUSTRIES NV]	Orfizip Light NS	1996-08-20
ITC Benny Arazy [ORFIT INDUSTRIES NV]	Tecnofit	1996-08-14
ITC Benny Arazy [ORFIT INDUSTRIES NV]	Orfilight	1996-08-14
ITC Benny Arazy [ORFIT INDUSTRIES NV]	Orfilight Black NS	1996-08-14
ITC Benny Arazy [ORFIT INDUSTRIES NV]	Aquafit NS	1996-08-14
LGF Benny Arazy [ORFIT INDUSTRIES NV]	Orficast Thermoplastic Tape	1996-08-07
IQI Benny Arazy [ORFIT INDUSTRIES NV]	Orfizip	1996-08-07
IQI Benny Arazy [ORFIT INDUSTRIES NV]	Orfizip Light NS	1996-08-07

Related Finance Registrations

NCAGE Code	B2270	ORFIT INDUSTRIES NV
CAGE Code	B2270	ORFIT INDUSTRIES NV

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082651966	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG
2020062357621	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG
2020060971891	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG
2020060971887	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG
202004228863	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL SUPPLIES	1 PKG
2020041517299	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL SUPPLIES	1 PKG
2020032454313	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG
2020012852100	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG