Built to Global Standards: ISO 13485, ISO 6710, IVDR and ISO 8
SEM Biotech, an internal division of SEM Plastik for medical products, focuses on manufacturing vacuum blood collection tubes.
From day one, our facility and product line have been aligned with globally recognized references such as ISO 13485:2016 (QMS for Medical Devices), ISO 6710:2017 (blood collection containers), CE marking under IVDR Class A (Sterile), and an ISO 8 cleanroom approach.
Our priority is to support laboratory safety, traceability, and consistent product quality through disciplined production processes.