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Home›Sweden›Elekta Instrument AB

Elekta Instrument AB

Sweden · Stockholm
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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
43510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 43 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
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
6active device licences
Class II 1Class III 4Class IV 1
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
5device registrations
CLASS B 1CLASS C 3CLASS D 1
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
1active ARTG entries
Class III 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
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 States0 registration records, 43 510(k), 0 PMA, 15 excluded
Brazil1 confirmed, 2 excluded
Canada6 confirmed, 3 excluded
Manufacturer names merged into this page: ELEKTA INSTRUMENT AB
Same-named companies — This database also contains companies with near-identical names: Elekta Instruments, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Sweden
City
Stockholm

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

41996
11997
21998
41999
12001
22003
32004
22005
22006
12007
12008
32009
12010
12012
12014
32015
22016
12017
22018
12019

Registration details (sample)

MarketIdentifierNameClass / date
USK190887Leksell Vantage Stereotactic System2019-08-01
USK173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon2018-03-30
USK173791Leksell GammaPlan2018-02-09
BR80569329001DISPOSABLE INSERTSClass I
CA15134LESKELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)Class III
CA64399LEKSELL SURGIPLANClass III
CA65232LEKSELL NEURO GENERATOR SYSTEMClass IV

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