FDA device listing

Zoomax Luna 6,Zoomax Snow 12,Zoomax Snow Pad

FDA device listing 2046351329 · ZOOMAX TECHNOLOGY CO., LIMITED

Key facts

Proprietary names Zoomax Luna 6,Zoomax Snow 12,Zoomax Snow Pad
Owner/operator ZOOMAX TECHNOLOGY CO., LIMITED
Owner/operator number 10058836
Product codes HJG
Device names HJG - System, Reading, Television, Closed-Circuit
Device class Class I
Classification regulations (21 CFR) 886.5820
Review panels Ophthalmic
Registered establishments ZOOMAX TECHNOLOGY CO., LIMITED
Establishment registrations 3014656175
FEI numbers 3014656175
Establishment operations Complaint File Establishment, Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Foreign Private Label Distributor, Manufacturer, Remanufacturer, Repackager/Relabeler, Reprocessor of Single Use Devices, Specification Developer
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

Browse all FDA device listings