NASAL IRRIGATION SOLUTIONS

Primary DI

08800132600237

Basic UDI-DI Code

88001326NS01-20LFAC

Reference

NS01-20LF

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

Not Intended For Eu Market

Manufacturer

LUCA AICELL, INC.

LUCA V-Defense Nasal Spray is a nasal spray medical device that protects against respiratory viral infections. Many countries that have suffered from the coronavirus pandemic have recently lifted the mandatory wearing of masks. LUCA V-Defense Nasal Spray is a minimal safety device that can prevent respiratory viral infections instead of masks. When V-Defense containing antibacterial lipid and lambda carrageenan is applied to the nasal and nasal mucosa, a physical antibacterial film is formed to prevent the penetration of viruses. The capacity is 20mL, equivalent to about 200 uses, and the nasal mucosa is coated with an antibacterial agent by putting spray nozzles in both nasal passages and spraying them once each. The coating maintenance time is about 4 to 5 hours, and it is recommended to use it 3 times a day normally. Various safety, stability, and efficacy tests have been completed, and KGMP, ISO13485, CE MDR, and FDA certifications have been obtained. Currently, we are exporting to Thailand, and they are sold through local pharmacies, Shopee, LAZADA, etc. As a result of the COVID-19 virus test at Mahidol University, a professional certification body in Thailand, 99.7% antiviral performance was confirmed within 1 minute.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).