FDA device listing

Catheter, Upper Urinary Tract - DeRoyal

FDA device listing 1413631444 · DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.

Key facts

Proprietary names Catheter, Upper Urinary Tract - DeRoyal
Owner/operator DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
Owner/operator number 9032613
Product codes EYC
Device names EYC - Catheter, Upper Urinary Tract
Device class Class II
Classification regulations (21 CFR) 876.5130
Review panels Gastroenterology & Urology
Registered establishments DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
Establishment registrations 9613793
FEI numbers 3006469671
Establishment operations Contract 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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