FDA device listing

Cathay

FDA device listing 1019985240 · Cathay Manufacturing Corp.

Key facts

Proprietary names Cathay
Owner/operator Cathay Manufacturing Corp.
Owner/operator number 9046141
Product codes DRX
Device names DRX - Electrode, Electrocardiograph
Device class Class II
Classification regulations (21 CFR) 870.2360
Review panels Cardiovascular
Registered establishments Cathay Manufacturing Corp.
Establishment registrations 3009555600
FEI numbers 3009555600
Establishment operations Contract Manufacturer, Foreign Exporter, 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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