FDA device listing

Guedel Airway For Single Use; Laryngeal Mask Airway

FDA device listing 1153819723 · Jiangxi Yiles Medical Co., Ltd

Key facts

Proprietary names Guedel Airway For Single Use; Laryngeal Mask Airway
Owner/operator Jiangxi Yiles Medical Co., Ltd
Owner/operator number 10053724
Product codes CAE
Device names CAE - Airway, Oropharyngeal, Anesthesiology
Device class Class I
Classification regulations (21 CFR) 868.5110
Review panels Anesthesiology
Registered establishments Jiangxi Yiles Medical Co., Ltd
Establishment registrations 3013576541
FEI numbers 3013576541
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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