FDA device listing

Aid, Transfer

FDA device listing 1843822910 · GCMEDICA ENTERPRISE LTD.(WUXI)

Key facts

Owner/operator GCMEDICA ENTERPRISE LTD.(WUXI)
Owner/operator number 10080904
Product codes IKX
Device names IKX - Aid, Transfer
Device class Class I
Classification regulations (21 CFR) 890.5050
Review panels Physical Medicine
Registered establishments GCMEDICA ENTERPRISE LTD.(WUXI)
Establishment registrations 3018503755
FEI numbers 3018503755
Establishment operations Contract 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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