FDA device listing

Aquaflush

FDA device listing 1424164540 · Vitalcare Trading (UK) Ltd.

Key facts

Proprietary names Aquaflush
Owner/operator Vitalcare Trading (UK) Ltd.
Owner/operator number 10057056
Product codes EXD
Device names EXD - Irrigator, Ostomy
Device class Class II
Classification regulations (21 CFR) 876.5895
Review panels Gastroenterology & Urology
Registered establishments CLINISUPPLIES (NANJING) CO., LTD
Establishment registrations 3014195785
FEI numbers 3014195785
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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