FDA device listing

Adaptor, Ureteral Catheter

FDA device listing 2010298733 · APPLIED MEDICAL RESOURCES

Key facts

Owner/operator APPLIED MEDICAL RESOURCES
Owner/operator number 2027111
Product codes EYI
Device names EYI - Adaptor, Ureteral Catheter
Device class Class I
Classification regulations (21 CFR) 876.5130
Review panels Gastroenterology & Urology
Registered establishments Applied Medical Distribution Center, Applied Medical Europe, APPLIED MEDICAL RESOURCES CORP.
Establishment registrations 2027111, 3009051888, 3009763019
FEI numbers 2027111, 3009051888, 3009763019
Establishment operations Complaint File Establishment, Manufacturer, Foreign Exporter
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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