FDA device listing

Powersorb

FDA device listing 1879576237 · REACH GLOBAL INDUSTRIES, INC.

Key facts

Proprietary names Powersorb
Owner/operator REACH GLOBAL INDUSTRIES, INC.
Owner/operator number 9033170
Product codes EXY
Device names EXY - Uroflowmeter
Device class Class II
Classification regulations (21 CFR) 876.1800
Review panels Gastroenterology & Urology
Registered establishments Qingdao Unison Industries Co., Limited
Establishment registrations 3005862693
FEI numbers 3005862695
Establishment operations Specification Developer
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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