FDA.reportPublic FDA data

BRAINCOOL AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30144269393014426939BRAINCOOL AB1N2026-01-01Scheelevagen 2 Lund Skane SE 22381

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2209651779357390K180375The IQoolTM Warm SystemDWJ2018-05-18
2209652017672000DEN210027The Cooral SystemQUA2022-10-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWJ22018-05-18
QUA12022-10-14

PMN#