Establishment registration

BIOTRONIK, INC.

FDA establishment registration 1028232 · LAKE OSWEGO, US

Key facts

Registration number 1028232
Establishment name BIOTRONIK, INC.
Owner/operator BIOTRONIK, INC.
Owner/operator number 1028232
FEI number 1028232
Address 6024 JEAN RD.
City LAKE OSWEGO
State OR
Country US
Registration valid through 2026
Product codes listed DQX, DQY, DRB, DRF, DTA, DTB, DTC, DTD, DTE, DXY, KRG, LIT, LOX, LWP, LWS, MRM, MXD, NIK, NKE, NVN, NVY, NVZ, OJX, OSR, OVJ
Device classes 2, 3

At a glance

  • 10–99 Device listings
  • 1,000+ UDI devices (GUDID)
  • Current Registration current
  • 10–99 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