FDA device listing

Face masks

FDA device listing 1496905538 · E-WAY VIET NAM COMPANY LIMITED

Key facts

Proprietary names Face masks
Owner/operator E-WAY VIET NAM COMPANY LIMITED
Owner/operator number 10087412
Product codes QKR
Device names QKR - Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
Device class Not classified
Classification regulations (21 CFR) ORCA1.QKR
Review panels General Hospital
Registered establishments E-WAY VIET NAM COMPANY LIMITED
Establishment registrations 3026603463
FEI numbers 3026603463
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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