FDA device listing

Catheter Fixation Device,Endotracheal Tube Holder,Tracheostomy Tube Holder

FDA device listing 1711059540 · Hangzhou Formed Medical Devices Co., Ltd.

Key facts

Proprietary names Catheter Fixation Device,Endotracheal Tube Holder,Tracheostomy Tube Holder
Owner/operator Hangzhou Formed Medical Devices Co., Ltd.
Owner/operator number 10052858
Product codes CBH
Device names CBH - Device, Fixation, Tracheal Tube
Device class Class I
Classification regulations (21 CFR) 868.5770
Review panels Anesthesiology
Registered establishments HANGZHOU FORMED MEDICAL DEVICES CO., LTD.
Establishment registrations 3013412170
FEI numbers 3013412170
Establishment operations Contract Manufacturer, 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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