FDA device listing

Europrosan,FLUFSAN

FDA device listing 1875824541 · EUROPROSAN SPA

Key facts

Proprietary names Europrosan,FLUFSAN
Owner/operator EUROPROSAN SPA
Owner/operator number 10091208
Product codes NNX
Device names NNX - Device, Incontinence, Urosheath Type, Non-Sterile
Device class Class I
Classification regulations (21 CFR) 876.5250
Review panels Gastroenterology & Urology
Registered establishments EUROPROSAN SPA
Establishment registrations 3011483384
FEI numbers 3011483384
Establishment operations Manufacturer, Specification Developer
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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