FDA.reportPublic FDA data

embecta medical I LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30245088193024508819embecta medical I LLC1Y2026-01-011329 West Highway 6 Holdrege NE US 68949

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3093981719953856K260208Ultra-Fine™ SAFETY Insulin SyringeFMF2026-07-13
3093981330307351K212499BD Insulin Syringe (0.3mL)FMF2022-03-09
3093981089210238K212015BD Nano 2nd Gen Pen NeedleFMI2021-11-19
3093981172130593K190054BD Insulin SyringeFMF2019-10-21
3093981314277596K151870BD U-500 INSULIN SYRINGEFMF2016-07-08
3093981098971462
3093981732549864

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMF42026-07-13
FMI12021-11-19