FDA device listing

Nasopharyngoscope (Flexible Or Rigid)

FDA device listing 1558570866 · FENTEX MEDICAL GMBH

Key facts

Owner/operator FENTEX MEDICAL GMBH
Owner/operator number 9093406
Premarket submissions K032822
Product codes EOB
Device names EOB - Nasopharyngoscope (Flexible Or Rigid)
Device class Class II
Classification regulations (21 CFR) 874.4760
Review panels Ear, Nose, & Throat
Registered establishments FENTEXMEDICAL GMBH
Establishment registrations 3006154292
FEI numbers 3006154292
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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