FDA device listing

Sunglasses

FDA device listing 1977519820 · DEM FACTORY S.R.L.

Key facts

Proprietary names Sunglasses
Owner/operator DEM FACTORY S.R.L.
Owner/operator number 10053242
Product codes HQY
Device names HQY - Sunglasses (Non-Prescription Including Photosensitive)
Device class Class I
Classification regulations (21 CFR) 886.5850
Review panels Ophthalmic
Registered establishments DEM FACTORY S.R.L.
Establishment registrations 3013507321
FEI numbers 3013507321
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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