FDA device listing

FRAME,POLASUP OPTICAL FRAME,ROMWE FRAME,SHEIN FRAME

FDA device listing 1654367772 · LINHAI SUNGERAS TRADING CO., LTD.

Key facts

Proprietary names FRAME,POLASUP OPTICAL FRAME,ROMWE FRAME,SHEIN FRAME
Owner/operator LINHAI SUNGERAS TRADING CO., LTD.
Owner/operator number 10084641
Product codes HQZ
Device names HQZ - Frame, Spectacle
Device class Class I
Classification regulations (21 CFR) 886.5842
Review panels Ophthalmic
Registered establishments LINHAI SUNGERAS TRADING CO., LTD.
Establishment registrations 3012978407
FEI numbers 3012978407
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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