FDA device listing

Eyeglass Frame,magnifying,Ophthalmic lenses,Prescription Spectacle Lenses,UV blockers glasses

FDA device listing 1587967347 · ZHENJIANG NEW SHUOYAN OPTICS CO.,LTD

Key facts

Proprietary names Eyeglass Frame,magnifying,Ophthalmic lenses,Prescription Spectacle Lenses,UV blockers glasses
Owner/operator ZHENJIANG NEW SHUOYAN OPTICS CO.,LTD
Owner/operator number 10079968
Product codes HQG
Device names HQG - Lens, Spectacle, Non-Custom (Prescription)
Device class Class I
Classification regulations (21 CFR) 886.5844
Review panels Ophthalmic
Registered establishments ZHENJIANG NEW SHUOYAN OPTICS CO.,LTD
Establishment registrations 3017965799
FEI numbers 3017965799
Establishment operations 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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