SEM Biotech is a biomedical manufacturing-focused brand operating in the field of vacuum blood collection systems. VACUSEM vacuum blood collection tubes are manufactured in accordance with ISO 8 cleanroom conditions, ISO 13485 quality management system and IVDR (EU 2017/746) regulations. With our standardized production processes, traceability infrastructure, and high-precision production technologies, we offer reliable solutions for laboratory diagnostic processes.
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Medical device quality management system standard.
Standards and color codes for blood collection containers.
Conformity approach under IVD legislation.
Process safety with controlled production environment.
SEM Biotech’s manufacturing setup is designed around internationally recognized medical device standards and cleanroom discipline.
Read MorePhase-1 capacity target is 384,000,000 tubes/year, with expansion planned through continued investment and broader product types.
Read MoreEnd-to-end manufacturing covers injection, filling, closure and assembly steps, supported by globally recognized partners for critical components.
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