FDA device listing

ulricheasyINJECT Max

FDA device listing 1076390752 · ULRICH GMBH & CO. KG

Key facts

Proprietary names ulricheasyINJECT Max
Owner/operator ULRICH GMBH & CO. KG
Owner/operator number 8010776
Premarket submissions K241850
Product codes IZQ
Device names IZQ - Injector, Contrast Medium, Automatic
Device class Class II
Classification regulations (21 CFR) 870.1650
Review panels Cardiovascular
Registered establishments ULRICH GMBH & CO. KG
Establishment registrations 9612420
FEI numbers 3002807156
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 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

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