ISO 13485:2016 · CE · FDA · RoHS +75529189390
Quality & Compliance

Certifications

TMIMED products are designed to meet international medical standards. The certification information below is sourced from content listed on the official website, subject to actual certificate documents, with relevant materials available on request.

ISO 13485:2016

ISO

ISO 13485:2016 medical device quality management system certification listed on the official website, covering design, production, traceability, and continuous improvement; certificate documents available on request.

CE

CE

CE-related certifications listed on the official website; relevant certificate documents available on request, subject to actual certificate documents.

FDA

FDA

FDA-related certifications listed on the official website, subject to actual certificate documents; materials available on request.

RoHS

RoHS

RoHS-related certifications listed on the official website, subject to actual certificate documents.

SGS Testing

SGS

SGS test reports listed on the official website, available on request, subject to actual test documents.

Invention Patent

Patent

TMIMED holds the invention patent for the innovative silicone fishbone tourniquet.

Quality Assurance

Compliant with International Medical Standards

Every product is manufactured under strict quality control and independently tested and certified — giving healthcare professionals and distributors confidence in every device.

Strict Quality Control

The ISO 13485:2016 quality management system covers design, production, traceability, and continuous improvement.

Global Market Compliance

CE, FDA, and RoHS compliance supports distribution in regulated markets such as Europe and North America.

Need Tourniquet Products with Certification Documents?

Request product literature, certificate documents, or samples — we can provide the materials distributors need for compliance on request.

Request Materials