FDA device listing

digital sensor holder,Digital sensor Positioner,Film Positioning System Complete,Imaging Plate Barrier…

FDA device listing 1910217953 · WUXI LYUSMILE IMP AND EXP CO.,LTD

Key facts

Proprietary names digital sensor holder,Digital sensor Positioner,Film Positioning System Complete,Imaging Plate Barrier Envelopers,position arm,position ring,Simple X-Ray Film Holder,X-ray Film Bag,X-ray Film Holder,X-ray Film Mounts-Clip On,X-ray Film Washer Clip,X-RAY Positioner
Owner/operator WUXI LYUSMILE IMP AND EXP CO.,LTD
Owner/operator number 10082225
Product codes EGZ
Device names EGZ - Holder, Film, X-Ray
Device class Class I
Classification regulations (21 CFR) 872.1905
Review panels Dental
Registered establishments WUXI LYUSMILE IMP AND EXP CO.,LTD
Establishment registrations 3021023132
FEI numbers 3021023132
Establishment operations Foreign Private Label Distributor
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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