FDA device listing

Hearing Aid

FDA device listing 2021987369 · Nuvomed Inc

Key facts

Proprietary names Hearing Aid
Owner/operator Nuvomed Inc
Owner/operator number 10059387
Product codes QUG
Device names QUG - Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
Device class Class II
Classification regulations (21 CFR) 874.3305
Review panels Ear, Nose, & Throat
Registered establishments NUVOMED INC
Establishment registrations 3014449259
FEI numbers 3014449259
Establishment operations Repackager/Relabeler
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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