Establishment registration

SMI MEDICAL INSTRUMENTS GMBH & CO.KG

FDA establishment registration 8010871 · NEUHAUSEN OB ECK Baden-Wurttemberg, DE

Key facts

Registration number 8010871
Establishment name SMI MEDICAL INSTRUMENTS GMBH & CO.KG
Owner/operator SMI MEDICAL INSTRUMENTS GMBH & CO KG
Owner/operator number 8010871
FEI number 6166
Address Robert Bosch Strasse 36
City NEUHAUSEN OB ECK Baden-Wurttemberg
Country DE
Registration valid through 2026
Product codes listed DWS, DXC, EPY, FHQ, GAC, GAD, GCJ, GDI, GDJ, GDZ, GEA, GEG, GEI, GEN, GFJ, GZX, HAW, HRR, HTD, HTX, HTZ, LRW, LRY, MDM
Device classes 1, 2

At a glance

  • 10–99 Device listings
  • 1,000+ 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