FDA device listing

Abdominal Binder

FDA device listing 1319175897 · HEBEI YOUJIE MEDICAL DEVICES CO., LTD

Key facts

Proprietary names Abdominal Binder
Owner/operator HEBEI YOUJIE MEDICAL DEVICES CO., LTD
Owner/operator number 10051650
Product codes KTD
Device names KTD - Orthosis, Abdominal
Device class Class I
Classification regulations (21 CFR) 890.3490
Review panels Physical Medicine
Registered establishments HEBEI YOUJIE MEDICAL DEVICES CO., LTD
Establishment registrations 3012464408
FEI numbers 3012464408
Establishment operations 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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