FDA device listing

Unit, Heating, Powered

FDA device listing 1641248779 · Gome Optical Lens Company Limited

Key facts

Owner/operator Gome Optical Lens Company Limited
Owner/operator number 10060498
Product codes IRQ
Device names IRQ - Unit, Heating, Powered
Device class Class I
Classification regulations (21 CFR) 890.5950
Review panels Physical Medicine
Registered establishments GOME OPTICAL LENS COMPANY LIMITED
Establishment registrations 3015392301
FEI numbers 3015392301
Establishment operations 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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