FDA device listing

Cement, Stomal Appliance, Ostomy

FDA device listing 1549470122 · Imperial Trading Limited

Key facts

Owner/operator Imperial Trading Limited
Owner/operator number 10036313
Premarket submissions K803100
Product codes EZR
Device names EZR - Cement, Stomal Appliance, Ostomy
Device class Class I
Classification regulations (21 CFR) 876.5900
Review panels Gastroenterology & Urology
Registered establishments IMPERIAL TRADING LIMITED
Establishment registrations 3000268902
FEI numbers 3000268902
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings