New Milestone Achieved, CE Mark for CARES4WOUNDS!

November 11, 2020 Pei Xin
milestone

We have reached a new milestone at Tetsuyu Healthcare Holdings! In 2019, Tetsuyu has secured its EN ISO:13485 certification. And was re-certified in 2020. Also in 2019, we have also listed CARES4WOUNDS C4W-A in HSA as a class A medical device.

 

This year, we have successfully registered CARES4WOUNDS C4W-B as a Class I medical device in the European Union (EU) and obtained the CE Mark in accordance with the EU’s Medical Device Directive 93/42/EEC as amended by 2007/47/EC.

 

“This is definitely a significant milestone in our commercialization journey. We have actually received great reviews from our pilot sites across Asia Pacific. The CE Mark allows us to systematically enter the big European markets such as Germany and the UK. The distribution of CARES4WOUNDS is made easy via mobile applications. The CE Mark allows us to leverage the demand for Telewounds especially during the COVID pandemic.” 

– Ng Li Lian, Co-founder of Tetsuyu Healthcare Holdings Pte Ltd

If you are keen to distribute our products or partner with us in the European market, feel free to contact us at info@tetsuyuhealthcare.com.