FDA device listing

PC SOL-utions

FDA device listing 1128042642 · BNL EUROLENS SA

Key facts

Proprietary names PC SOL-utions
Owner/operator BNL EUROLENS SA
Owner/operator number 10028479
Product codes HQG
Device names HQG - Lens, Spectacle, Non-Custom (Prescription)
Device class Class I
Classification regulations (21 CFR) 886.5844
Review panels Ophthalmic
Registered establishments BNL EUROLENS SA
Establishment registrations 3000189209
FEI numbers 3000189209
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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