FDA.reportPublic FDA data

BIOTRACKER LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
BIOTRACKER LLC5N2027-01-0119900 E Country Club Dr Ph 4 Aventura FL US 33180

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3540611445322535K253306BioTracker 2.0MWI2026-06-26
3540611355884405

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWI12026-06-26