FDA device listing

Lens, spectacle (prescription), for reading discomfort

FDA device listing 1816631613 · GREAT DRAGON OPTICAL (FUJIAN) CO.LTD

Key facts

Proprietary names Lens, spectacle (prescription), for reading discomfort
Owner/operator GREAT DRAGON OPTICAL (FUJIAN) CO.LTD
Owner/operator number 9044805
Product codes NJH
Device names NJH - Lens, Spectacle (Prescription), For Reading Discomfort
Device class Class I
Classification regulations (21 CFR) 886.5844
Review panels Ophthalmic
Registered establishments GREAT DRAGON OPTICAL (FUJIAN) CO.LTD
Establishment registrations 3004134915
FEI numbers 3004134915
Establishment operations Foreign Exporter, 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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