FDA device listing

DMI

FDA device listing 1538469631 · DMS HOLDINGS DBA HealthSmart International

Key facts

Proprietary names DMI
Owner/operator DMS HOLDINGS DBA HealthSmart International
Owner/operator number 9005245
Product codes EYQ
Device names EYQ - Garment, Protective, For Incontinence
Device class Class I
Classification regulations (21 CFR) 876.5920
Review panels Gastroenterology & Urology
Registered establishments DMS HOLDINGS, INC.,
Establishment registrations 1422443
FEI numbers 1000143485
Establishment operations Complaint File Establishment
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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