Establishment registration

Sysmex America, Inc.

FDA establishment registration 3009495621 · Buffalo Grove, US

Key facts

Registration number 3009495621
Establishment name Sysmex America, Inc.
Owner/operator SYSMEX CORPORATION
Owner/operator number 9014170
FEI number 3009495621
Address SAI - Multi-Purpose Building
City Buffalo Grove
State IL
Country US
Registration valid through 2026
Product codes listed CDM, CEN, GKB, GKL, GKP, GKZ, JIL, JIN, JIO, JIR, JIX, JJB, JMT, JOY, JPA, JRE, KPA, KQO, LJX, LKM, LXG, PER
Device classes 1, 2

At a glance

  • 10–99 Device listings
  • 1–9 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