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ORFIT INDUSTRIES NV

Belgium · Wijnegem Antwerpen

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

16listed device types

Class I 13Class II 3Class III 0

plus 29 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 9Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

13registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States29 registration records, 11 510(k), 0 PMA

Brazil12 confirmed, 0 excluded

Saudi Arabia13 confirmed, 0 excluded

Manufacturer names merged into this page: ORFIT INDUSTRIES NV · ORFIT INDUSTRIES N.V. · Orfit Industries

FDA 510(k) clearances by year

11999

12013

12014

22015

22016

12017

12019

22020

FDA listed device types

showing 8 of 16

Accelerator, Linear, Medical 1System, Radiation Therapy, Charged-Particle, Medical 1Table, Radiologic 1Orthosis, Limb Brace 1Orthosis, Lumbar 1Component, Cast 1Orthosis, Truncal/Orthosis, Limb 1Component, External, Limb, Ankle/Foot 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202068	The AIO Solution 3.0	2020-08-14
US	K200282	Orfit Aerial Couchtop	2020-04-08
US	K191158	The AIO Solution	2019-08-06
BR	81191340009	Imobilizador de paciente para Radioterapia - Orfit	Class I
BR	81191340010	IMOBILIZADOR PARA TRATAMENTO DE CÂNCER - ORFIT	Class II
BR	81191340001	Grânulos Termoplásticos	Class I
SA	ME0000001936SFDAA00008	DUON	—
SA	ME0000001936SFDAA00009	Raycast	—

ORFIT INDUSTRIES NV

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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