FDA device listing

Speculum, Rectal

FDA device listing 1172468509 · Well care (Wuhan) medical technology Co., Ltd.

Key facts

Proprietary names Speculum, Rectal
Owner/operator Well care (Wuhan) medical technology Co., Ltd.
Owner/operator number 10084681
Product codes FFQ
Device names FFQ - Speculum, Rectal
Device class Class I
Classification regulations (21 CFR) 876.4730
Review panels Gastroenterology & Urology
Registered establishments WELL CARE (WUHAN) MEDICAL TECHNOLOGY CO., LTD.
Establishment registrations 3022555975
FEI numbers 3022555975
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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