FDA device listing

Spectacle, Magnifying

FDA device listing 1726592570 · Pioneer Optical (Shenzhen) Company Limited

Key facts

Owner/operator Pioneer Optical (Shenzhen) Company Limited
Owner/operator number 10055034
Product codes HOI
Device names HOI - Spectacle, Magnifying
Device class Class I
Classification regulations (21 CFR) 886.5840
Review panels Ophthalmic
Registered establishments PIONEER OPTICAL (SHENZHEN) COMPANY LIMITED
Establishment registrations 3013587731
FEI numbers 3013587731
Establishment operations Contract Manufacturer, 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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