Establishment registration

HISMILE PTY LTD

FDA establishment registration 3014610038 · BURLEIGH WATERS Queensland, AU

Key facts

Registration number 3014610038
Establishment name HISMILE PTY LTD
Owner/operator HiSmile Pty Ltd
Owner/operator number 10057830
FEI number 3014610038
Address 225-229 BURLEIGH CONNECTION ROAD
City BURLEIGH WATERS Queensland
Country AU
Establishment types Specification developer, Foreign private label distributor
Registration valid through 2026
Product codes listed EEG, EFT, EFW, EHY, JEQ, JES
Device classes 1

At a glance

  • 1–9 Device listings
  • None UDI devices (GUDID)
  • Current Registration current
  • None FDA inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device establishment registrations

Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device establishment registrations