Establishment registration

CARDIOGARD USA, INC

FDA establishment registration 3011427673 · Tyngsboro, US

Key facts

Registration number 3011427673
Establishment name CARDIOGARD USA, INC
Owner/operator CardioGard USA, Inc
Owner/operator number 10048779
FEI number 3011427673
Address 100 Business Park Dr. #5
City Tyngsboro
State MA
Country US
Establishment types Specification developer
Registration valid through 2026
Product codes listed DWF
Device classes 2

At a glance

  • 1–9 Device listings
  • 1–9 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