Noble has obtained three important certificates including the medical device production license
In 2022, Noble won good news continuously. With the professional R&D team, strong technical strength, continuous innovation ability, and scientific
enterprise management, with the full cooperation and efforts of various departments, Noble obtained the ISO13485- After the 2016 system certificate,
Noble has successively obtained three important certificates to enter the medical device industry, namely:
On October 31, 2022, it obtained the medical device registration certificate of the M05 product series approved by the Drug Administration of Guangxi
Zhuang Autonomous Region.
Obtained the US FDA 510K certificate on November 17, 2022.
On January 6, 2023, it obtained the medical device production license approved by the Guangdong Provincial Drug Administration.
Noble is an enterprise that obtained the medical device registration certificate and production license earlier in the domestic IPL intense
pulsed light therapeutic instrument industry, which is a sign that Noble has obtained the qualification for medical device market access.
The FDA 510K certificate allows us to obtain a passport to the international medical device market represented by the United States.
The acquisition of all these qualifications and certificates has opened a new journey for Noble in the field of intelligent nursing products.
About Noble
NOBLE is a Sino-British joint venture awarded "National High-tech Enterprise" by the government. Mainly focus on Smart Manufacturing
business and product business two business directions.
product business has been devoting to becoming a leading provider of intelligent care products and services, focusing on the three major
areas of beauty care, health care and elderly care.
Since 2012, we have developed laser hair removal products and entered the personal care market. And began to involve in the design and
development of intelligent care products, and formed our own unique advantages in this field. Over the past few years, we have successively
developed more than ten IPL hair removal devices with great product power. At the same time, a number of health and elderly care products
are also under development.
“Smart Manufacturing” business mainly focuses on medical, automotive, robotics and other fields,specializes in providing customers with
projects supporting services including parts machining and manufacturing.
We have obtained dual quality system certification, ISO9001-2015 product quality certification and ISO13485-2016 medical device quality
certification,China medical device Registration Certificate and production license, the United States FDA 510K certificate, and will continue to
obtain the EU MDR, Japan JGMP and other related medical qualifications and certifications.