Establishment registration

Gold Standard Diagnostics Frankfurt GmbH

FDA establishment registration 3008191245 · Dietzenbach Hesse, DE

Key facts

Registration number 3008191245
Establishment name Gold Standard Diagnostics Frankfurt GmbH
Owner/operator Gold Standard Diagnostics
Owner/operator number 10031124
FEI number 3008191245
Address Waldstrasse 23 A6
City Dietzenbach Hesse
Country DE
Registration valid through 2026
Product codes listed GNH, GPF, GSM, KHW, LJZ, LSR, MDJ, MDT
Device classes 1, 2

At a glance

  • 10–99 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