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Home›Sweden›Raysearch Laboratories AB

Raysearch Laboratories AB

Sweden · Stockholm
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
1listed device types
Class I 0Class II 1Class III 0
plus 12 registration records and 22 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
2 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class III 2
4 including historic records
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 States12 registration records, 22 510(k), 0 PMA, 1 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: RaySearch Laboratories AB (publ) · RAYSEARCH LABORATORIES AB (PUBL)
Same-named companies — This database also contains companies with near-identical names: RaySearch Laboratories AB (publ). 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

12008
12009
12010
12012
12013
22014
12016
22017
12018
22019
22020
22021
12022
12023
32025

FDA listed device types

System, Planning, Radiation Therapy Treatment 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252109RayStation (2024A SP3)2025-12-22
USK242992RayCare (2024A SP1)2025-04-17
USK240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP32025-04-04
CA83114SHAREPLAN (RADIATION TREATMENT PLANNING SOFTWARE)Class III
CA95225INVERSEARC 1.0Class III

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