FDA device listing

PE Apron, PEVA Apron, POE Apron, TPU Apron, Vinyl Apron

FDA device listing 1717592352 · DONGGUAN LUDA INDUSTRIAL CO., LTD

Key facts

Proprietary names PE Apron, PEVA Apron, POE Apron, TPU Apron, Vinyl Apron
Owner/operator DONGGUAN LUDA INDUSTRIAL CO., LTD
Owner/operator number 10064188
Product codes IWO
Device names IWO - Apron, Protective
Device class Class I
Classification regulations (21 CFR) 892.6500
Review panels Radiology
Registered establishments DONGGUAN LUDA INDUSTRIAL CO., LTD
Establishment registrations 3016704566
FEI numbers 3016704566
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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