FDA device listing

Nasal Spray, Ent Delivery

FDA device listing 1858075420 · Shenzhen Homed Medical Device Co., Ltd

Key facts

Owner/operator Shenzhen Homed Medical Device Co., Ltd
Owner/operator number 10041952
Product codes KCO
Device names KCO - Nasal Spray, Ent Delivery
Device class Class I
Classification regulations (21 CFR) 874.5220
Review panels Ear, Nose, & Throat
Registered establishments SHENZHEN HOMED MEDICAL DEVICE CO LTD
Establishment registrations 3010287621, 3013000203
FEI numbers 3010287621, 3013000203
Establishment operations Manufacturer, Specification Developer
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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