FDA.reportPublic FDA data

RaySearch Laboratories AB (publ)

Matched from indexed company URL: RAYSEARCH LABORATORIES AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30077744653007774465RaySearch Laboratories AB (publ)1N2026-01-01EUGENIAVAEGEN 18C Stockholm SE 11368

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1065392004713199K242992RayCare (2024A SP1)MUJ2025-04-17
1065391267132705K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3MUJ2025-04-04
1065391377992400K222312RayStation 12AMUJ2023-03-29
1065391227845028K220141RayStation 11BMUJ2022-04-15
1065391581770143K211867RayStation 11.0MUJ2021-09-08
1065391249039173K210645RayStation 10.1MUJ2021-06-29
1065391744007575K200569RayStationMUJ2020-09-24
1065392057852589K200487RayCare 3.1MUJ2020-06-10
1065391780357001K190387RayStationMUJ2019-06-19
1065391331537527K180379RayStation 7MUJ2018-04-25
1065391163627769K171536RayStationMUJ2017-06-27
1065391125222552K170355RayStation 6MUJ2017-03-02
1065391870854047K160093RayStationMUJ2016-04-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MUJ172025-04-17

PMN#

RayStation

2020-09-24

RaySearch Laboratories AB (publ)

RayStation

2019-06-19

RaySearch Laboratories AB (publ)

RayStation

2017-06-27

RaySearch Laboratories AB (publ)

RayStation

2016-04-08

RaySearch Laboratories AB (publ)

RAYDOSE

2008-10-22

RAYSEARCH LABORATORIES AB

GUDID#

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