Establishment registration

FCI SAS

FDA establishment registration 9615745 · BESANCON Doubs, FR

Key facts

Registration number 9615745
Establishment name FCI SAS
Owner/operator Carl Zeiss Meditec AG (Jena)
Owner/operator number 9053564
FEI number 3000314405
Address 2 rue Carl Zeiss
City BESANCON Doubs
Country FR
Establishment types Complaint file establishment
Registration valid through 2026
Product codes listed DQO, HJK, HJL, HJZ, HMX, HNC, HND, HNF, HNL, HNN, HNP, HNQ, HNR, HNW, HOY, HPZ, HQB, HQF, HQN, HQX, JYJ, LZU, MML, MPA, MQU, MXY, NCB, NFM, NGY, OKS
Device classes 1, 2, U

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