FDA.reportPublic FDA data

ORFIT INDUSTRIES NV

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96131831000227792ORFIT INDUSTRIES NV1N2026-01-019A, VOSVELD WIJNEGEM Antwerpen BE B-2110

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05401172003861Orfit - Arm Strap – Extended Velcro+1(888)673-4903welcome@orfit.com
05401172011170The AIO Solution - 32006-V2+1(888)673-4887welcome@orfit.com
05401172011439The AIO Solution - 32015/8+1(888)673-4887welcome@orfit.com
05401172011477The AIO Solution - 32015/9+1(888)673-4887welcome@orfit.com
05401172011491The AIO Solution - 32015/9/1+1(888)673-4887welcome@orfit.com
05401172011514The AIO Solution - 32015/9/2+1(888)673-4887welcome@orfit.com
05401172011552The AIO Solution - 32015/9/3+1(888)673-4887welcome@orfit.com
05401172018216Orfit - 35674/10+1(888)673-4887welcome@orfit.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
156071779458843K991319RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALSIYE1999-09-21
156071610055778K930246MAMMORXIYE1993-07-26
156071010939814K202068The AIO Solution 3.0IYE2020-08-14
156071392518706K200282Orfit Aerial CouchtopLHN2020-04-08
156071236638308K191158The AIO SolutionIYE2019-08-06
156071986766335K171734HP PRO Positioning DeviceIYE2017-07-25
156071861996843K162862Raycast High Precision Lung Board SolutionIYE2016-11-09
156071133592736K162355Raycast MammoRx Carbon Fibre Breast BoardIYE2016-11-22
156071496260049K151946ThermofitIYE2015-11-09
156071862053134K151207Proton Immobilization SolutionIYE2015-07-28
156071169367635K141787SAGITTILTIYE2014-08-07
156071619556212K131795NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALSIYE2013-09-26
156071739413360K050888INTEGRA IMMOBILIZATION SYSTEMIYE2005-05-23
156071016023706
156071065572483
156071160423146
156071179612634
156071231872723
156071330217112
156071341139070
156071392162774
156071454870395
156071509656601
156071569982100
156071587465727
156071752885285
156071986768233
156071990508546
156072071640884

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE122020-08-14
LHN12020-04-08

PMN#

GUDID#

200 records. Showing 1-40. Next