FDA device listing

FE102: Flexible Nasopharyngoscope,Nasopharyngoscope Flexible

FDA device listing 1968869876 · EUSA GLOBAL LLC

Key facts

Proprietary names FE102: Flexible Nasopharyngoscope,Nasopharyngoscope Flexible
Owner/operator EUSA GLOBAL LLC
Owner/operator number 10034454
Premarket submissions K821181
Product codes EQN
Device names EQN - Laryngoscope, Nasopharyngoscope
Device class Class II
Classification regulations (21 CFR) 874.4760
Review panels Ear, Nose, & Throat
Registered establishments EUSA GLOBAL LLC
Establishment registrations 3007532396
FEI numbers 3007532396
Establishment operations Repackager/Relabeler
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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