Establishment registration

Masimo Medical Technologies (Malaysia) SDN BHD

FDA establishment registration 3027256461 · Pasir Gudang Johor, MY

Key facts

Registration number 3027256461
Establishment name Masimo Medical Technologies (Malaysia) SDN BHD
Owner/operator MASIMO CORPORATION
Owner/operator number 9031881
FEI number 3027256461
Address Lot 198511 (PLO 547-A) & Lot 198512 (PLO 547-B), Jalan Keluli 11, Zon 12A Kawasan Perindustrian Pasir Gudang
City Pasir Gudang Johor
Country MY
Registration valid through 2026
Product codes listed BZQ, CAT, CBQ, CBR, CBS, CCK, CCL, DPZ, DQA, DXN, FLL, GWQ, GXY, JKS, MWI, NHO, NHP, NHQ, OLT, OLW, OMC, ORT, QWE
Device classes 1, 2

At a glance

  • 10–99 Device listings
  • 1,000+ 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