FDA device listing

HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)

FDA device listing 1987439188 · Shenzhen Youmay Electronics Co., Ltd

Key facts

Proprietary names HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
Owner/operator Shenzhen Youmay Electronics Co., Ltd
Owner/operator number 10073424
Product codes KFZ
Device names KFZ - Humidifier, Non-Direct Patient Interface (Home-Use)
Device class Class I
Classification regulations (21 CFR) 868.5460
Review panels Anesthesiology
Registered establishments SHENZHEN YOUMAY ELECTRONICS CO., LTD
Establishment registrations 3017265430
FEI numbers 3017265430
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

Browse all FDA device listings