Establishment registration

Hardy Diagnostics

FDA establishment registration 3009547954 · Springboro, US

Key facts

Registration number 3009547954
Establishment name Hardy Diagnostics
Owner/operator HARDY DIAGNOSTICS
Owner/operator number 2022807
FEI number 3009547954
Address 429 S Pioneer Blvd
City Springboro
State OH
Country US
Establishment types Contract manufacturer, Specification developer, Remanufacturer, Export-only manufacturer
Registration valid through 2026
Product codes listed JCE, JSC, JSD, JSE, JSF, JSG, JSH, JSI, JSJ, JSM, JSO, JTS, JTY, JTZ, KKW, KPA, KQC, KZI, LJG, PPM, PQZ
Device classes 1, 2

At a glance

  • 10–99 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