Establishment registration

BIOTEKE USA LLC

FDA establishment registration 3028746593 · Miami, US

Key facts

Registration number 3028746593
Establishment name BIOTEKE USA LLC
Owner/operator Bioteke USA LLC
Owner/operator number 10088753
FEI number 3028746593
Address 900 Brickell Key Blvd Suite 2304
City Miami
State FL
Country US
Establishment types Repackager/relabeler, Remanufacturer, Single-use device reprocessor
Registration valid through 2026
Product codes listed QKP
Device classes N

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