FDA device listing

Urine Bag for Legs, Urine Bag Pediatric, Urine Bag Pear Shape with Drainage Tube

FDA device listing 1075149813 · Zhejiang Anji Huabu Industrial Co., Ltd.

Key facts

Proprietary names Urine Bag for Legs, Urine Bag Pediatric, Urine Bag Pear Shape with Drainage Tube
Owner/operator Zhejiang Anji Huabu Industrial Co., Ltd.
Owner/operator number 9045080
Product codes EXG
Device names EXG - Bag, Urine Collecting, Ureterostomy
Device class Class I
Classification regulations (21 CFR) 876.5900
Review panels Gastroenterology & Urology
Registered establishments ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD.
Establishment registrations 9710020
FEI numbers 3003340795
Establishment operations 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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