FDA device listing

Optical Frame

FDA device listing 1833289717 · WENZHOU SAMEWAY OPTICAL CO.,LTD

Key facts

Proprietary names Optical Frame
Owner/operator WENZHOU SAMEWAY OPTICAL CO.,LTD
Owner/operator number 10057573
Product codes HQZ
Device names HQZ - Frame, Spectacle
Device class Class I
Classification regulations (21 CFR) 886.5842
Review panels Ophthalmic
Registered establishments WENZHOU SAMEWAY OPTICAL CO.,LTD
Establishment registrations 3014527836
FEI numbers 3014527836
Establishment operations Contract Manufacturer, 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

Browse all FDA device listings