FDA device listing

Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

FDA device listing 1190882998 · XIAMEN SUN HAVEN OPTICAL CO., LTD.

Key facts

Owner/operator XIAMEN SUN HAVEN OPTICAL CO., LTD.
Owner/operator number 9104220
Product codes HOY
Device names HOY - Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Device class Class I
Classification regulations (21 CFR) 886.4750
Review panels Ophthalmic
Registered establishments XIAMEN SUN HAVEN OPTICAL CO., LTD.
Establishment registrations 3006752097
FEI numbers 3006752097
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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