AMBU Limited

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30039241863003924186AMBU Limited1N2027-01-01No.C, Warehouse & Process Complex Building XIANG YU F.T.Z., XIAMEN Fujian CN 361006

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
89521497021989K993278AMBU NEONATE SILICONE RESUSCITATORBTM2000-05-17
89521760557343K981891AMBU TUBECHECKBTR1998-07-17
89521713127728K900260AMBU LIFE KEY AND AMBU RES-CUE KEYBTM1990-06-08
89521562702340K840349MARK III RESUSCITATORBTM1984-02-10
89521104763490K102824AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRICBTM2011-01-28
89521499052840
89521531894230
89521688886086
89521968203157
89521080107972
89521096961954
89521486714884
89521615685059
89521712991993
89521715242768
89521717185553
89521776815027
89521797921953
89521854205592
89521881294100
89521899484576
89521906895138
89521945849410

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BTM42011-01-28
BTR11998-07-17