FDA device listing

SAFILO,SAFILO SPA

FDA device listing 1898818791 · SAFILO S.P.A.

Key facts

Proprietary names SAFILO,SAFILO SPA
Owner/operator SAFILO S.P.A.
Owner/operator number 9049745
Product codes HQZ
Device names HQZ - Frame, Spectacle
Device class Class I
Classification regulations (21 CFR) 886.5842
Review panels Ophthalmic
Registered establishments SAFILO S.P.A.
Establishment registrations 3003116697
FEI numbers 3003116697
Establishment operations Contract Manufacturer, Manufacturer, Repackager/Relabeler
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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