FDA device listing

Shoe Cover

FDA device listing 1535248768 · NINGBO Chibanda IMP &EXP CO, LTD

Key facts

Proprietary names Shoe Cover
Owner/operator NINGBO Chibanda IMP &EXP CO, LTD
Owner/operator number 10058628
Product codes FXP
Device names FXP - Cover, Shoe, Operating-Room
Device class Class I
Classification regulations (21 CFR) 878.4040
Review panels General & Plastic Surgery
Registered establishments NINGBO CHIBANDA IMP &EXP CO, LTD
Establishment registrations 3014437893
FEI numbers 3014437893
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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