Establishment registration

CARDIOFOCUS, INC.

FDA establishment registration 1225698 · Marlborough, US

Key facts

Registration number 1225698
Establishment name CARDIOFOCUS, INC.
Owner/operator CARDIOFOCUS, INC.
Owner/operator number 9026178
FEI number 3001451473
Address 500 NICKERSON ROAD
City Marlborough
State MA
Country US
Establishment types Export-only manufacturer
Registration valid through 2026
Product codes listed DRA, DYB, OAE, OCM
Device classes 2, 3

At a glance

  • 1–9 Device listings
  • 10–99 UDI devices (GUDID)
  • Current Registration current
  • 1–9 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