Certificates & Test Reports
At DECOTRA, we provide a wide array of medical products, manufactured in Vietnam with closed technology lines with certifications from ISO and international standards for globalization.
In addition, DECOTRA also meets the specifications and quality criteria of masks synthesized from the requirements of European Standard EN 14683, American Standard ASTM 2100 and NIOSH method through the test reports of prestigious laboratories such as Nelson, SGS and Bureau Veritas
International Recognition for Decotra
The U.S. Food and Drug Administration (FDA) is the government agency of the United States responsible for reviewing, approving, regulating and controlling the safety of food & drugs.
The CE marking is the manufacturer’s declaration that the product meets EU standards for health, safety, and environmental protection.
D‑U‑N‑S Numbers are often referenced by lenders and potential business partners to help predict the reliability and/or financial stability of the company in question.
The United States Patent and Trademark Office (USPTO) is the federal agency for granting U.S. patents and registering trademarks.
The World Intellectual Property Organization (WIPO) is the global forum for intellectual property (IP) services, policy, information and cooperation.
ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
ASTM F2100, EN 14863 and NIOSH are technical methods to test the performance of materials making medical masks in demanding markets such as the United States and Europe.