St Biotech lab consumables have been certified by several global entities. We can provide all test certifications upon your request. All our products are well qualified in North American and European regions, and several other oversea regions as well.
TÜV CE Certification:
Earning the esteemed TÜV CE certification is a testament to the rigorous safety testing undergone by St Biotech products. This certification guarantees the absence of defects or potentially hazardous materials, demonstrating full compliance with national, regional, and international regulations. Your safety and peace of mind are our top priorities.
ISO 13485:
Our adherence to ISO 13485 reflects our commitment to aligning with global regulatory standards, including MDR and U.S. FDA requirements. This certification places a strong emphasis on comprehensive risk management across the entire product lifecycle, encompassing design, development, production, installation, and servicing. Rest assured, your trust in our products is well-placed.
MDR Standards Compliance:
Under the Medical Device Regulation (MDR), St Biotech products must undergo a thorough conformity assessment. This crucial process verifies compliance with stringent safety and performance requirements set forth by regulatory authorities. These assessments are conducted by notified bodies, specialized organizations appointed by EU member states to meticulously oversee the conformity assessment process.
CIBG Certification:
Our CIBG certification, issued by the Netherlands Ministry of Health, is a mark of excellence in medical standards. This endorsement signifies compliance with the stringent health and safety requirements set forth by Dutch authorities. Trust in our products, backed by the seal of approval from one of the most respected health ministries in the world.
SGS Certification:
At St Biotech, we hold ourselves to the highest global standards, and our SGS certification attests to that commitment. SGS is a renowned multinational company that sets the benchmark for quality across industries worldwide. Rest assured, when you choose our products, you're selecting excellence backed by an internationally recognized authority.
SUNGO CE Certification:
Endorsed by SUNGO, a distinguished CE certificate issuing authority based in the Netherlands, our products meet the highest European standards for medical items. This certification ensures compliance with rigorous safety and performance requirements, providing you with the assurance of quality and reliability. Choose St Biotech for products that meet and exceed international benchmarks for excellence.
