FDA device listing

Waste Management System

FDA device listing 1682868386 · SUZHOU MECCAN IMP. & EXP. CORPORATION

Key facts

Proprietary names Waste Management System
Owner/operator SUZHOU MECCAN IMP. & EXP. CORPORATION
Owner/operator number 9045121
Premarket submissions K904994
Product codes DXT
Device names DXT - Injector And Syringe, Angiographic
Device class Class II
Classification regulations (21 CFR) 870.1650
Review panels Cardiovascular
Registered establishments Suzhou Meccan Import and Export Corp.
Establishment registrations 3001650535
FEI numbers 3001650535
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

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