FDA device listing

Antibac bandages

FDA device listing 1053944456 · ALLMED MEDICAL PRODUCTS CO., LTD.

Key facts

Proprietary names Antibac bandages
Owner/operator ALLMED MEDICAL PRODUCTS CO., LTD.
Owner/operator number 9033718
Premarket submissions K113583
Product codes FRO
Device names FRO - Dressing, Wound, Drug
Device class Unclassified
Classification regulations (21 CFR) ORCA1.FRO
Review panels General & Plastic Surgery
Registered establishments Allmed Industrial Limited, ALLMED MEDICAL PRODUCTS CO., LTD.
Establishment registrations 3004950768, 3011089435, 3011862887
FEI numbers 3004950768, 3011089435, 3011862887
Establishment operations Contract Manufacturer, Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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