FDA device listing

ROOE Medical Washing Sink, Wash Stand, Medical Hand Sink, Washing Tank, Washing Tub

FDA device listing 2062652773 · Jiangsu Rooe Medical Technology Co., Ltd.

Key facts

Proprietary names ROOE Medical Washing Sink, Wash Stand, Medical Hand Sink, Washing Tank, Washing Tub
Owner/operator Jiangsu Rooe Medical Technology Co., Ltd.
Owner/operator number 10091569
Product codes ITJ
Device names ITJ - Walker, Mechanical
Device class Class I
Classification regulations (21 CFR) 890.3825
Review panels Physical Medicine
Registered establishments JIANGSU ROOE MEDICAL TECHNOLOGY CO., LTD.
Establishment registrations 3014739961
FEI numbers 3014739961
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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