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ELEKTA LIMITED

USA · St. Charles

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Israel, Russia — 6 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

7listed device types

Class I 0Class II 7Class III 0

plus 15 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

23active device licences

Class II 8Class III 15

25 including historic records

TWTaiwanTFDA

4valid device licences

Class I 3Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

21registrations

RURussiaRoszdravnadzor

3active registrations

Class 2b 3

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 States15 registration records, 22 510(k), 0 PMA, 12 excluded

Brazil0 confirmed, 3 excluded

Canada23 confirmed, 2 excluded

Manufacturer names merged into this page: Elekta Inc. · ELEKTA LIMITED · ELEKTA, INC.

FDA 510(k) clearances by year

22005

22008

22010

22011

32012

22013

12014

12015

32018

32019

12021

FDA listed device types

System, Applicator, Radionuclide, Remote-Controlled 1System, Therapeutic, X-Ray 1System, Simulation, Radiation Therapy 1System, Nuclear Magnetic Resonance Imaging 1Accelerator, Linear, Medical 1System, Radiation Therapy, Radionuclide 1Block, Beam-Shaping, Radiation Therapy 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210500	Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD	2021-06-11
US	K192482	Elekta Unity	2019-12-05
US	K192242	Synergy Platform, Synergy, Infinity, VersaHD	2019-11-22
CA	6504	VIEWSTATION	Class II
CA	6510	MLC FIT	Class II
CA	13100	SEQUENCER	Class III

ELEKTA LIMITED

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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