GIGALAB® completed the recertification audit for CE Mark Certification. Moreover, the scope of the certification includes the 1. Urichrome, Milieu Chromogène 2. Candida Chromium, Chromogenic Medium 3. Salmonella Chromium, Chromogenic Medium 4. StrepB-Chromium, Chromogenic Medium 5. Campylo-Chromium, Chromogenic Medium 6. Yersinia-Chromium, Chromogenic Medium 7. C.diff-Chromium, Chromogenic Medium 8. Pylori Agar 9. Columbia Agar + 5% Sheep Blood 10. Columbia ANC Agar + 5% Sheep Blood 11. Multivita Chocolate Agar 12. VCN Multivita Chocolate Agar 13. Sabouraud Chloramphenicol Agar 14. Sabouraud Chloramphenicol + Actidione Agar 15. SMAC CT Agar 16. Cetrimide Agar 17. MacConkey Agar 18. Drigalski Agar 19. SS Agar 20. Hektoen Agar 21. CLED Agar 22. Chapman Agar 23. Mueller Hinton Agar 24. Mueller Hinton + 5% Sheep Blood Agar 25. BCP Agar 26. Legionella GVPC Agar 27. GLD COVID 19 Ag 28. GLD VIH 1+2 Test 29. GLD HCV Test 30. GLD HCG Test 31. GLD Monkeypox virus test.
Apart from this, GIGALAB® can also apply for Good Manufacturing Practices (GMP) Certification to show that the organziation is committed to maintaining consistent product quality and compliance with regulations. The organization can apply for ISO 9001:2015 Certification for Quality Management System (QMS).
GIGALAB® can apply for ISO/IEC 27701:2019 certification and ISO/IEC 27001:2022 certification to enhance its information security and data privacy. Moreover, the organization can also apply for ISO 41001:2018 Certification for Facility Management – Management System to adopt the best facility management practices.
What is CE Mark Certification?
The CE Mark is a certification symbol that attests to a product’s compliance with the safety, health, and environmental standards established by the European Union. The certification is necessary for items supplied within the European Economic Area (EEA) and applies to various products, including electronics, machinery, medical devices, and building materials. The CE Mark attests to the product’s compliance with EU laws and eligibility for unfettered trade across the European Economic Area. This accreditation facilitates trade while ensuring product safety and quality in the European market.
Benefits of CE Mark Certification for GIGALAB®
The benefits of CE Mark certification for GIGALAB® are as follows:
- The CE mark facilitates GIGALAB® legal entry into the European market. Furthermore, the standard demonstrates the organization’s compliance with European guidelines for selling medical devices within the European Economic Area (EEA).
- The CE Mark Certification indicates GIGALAB®’s products follow high-quality standards and demonstrate its compliance with European standards. The certification also strengthens the organization’s credibility and marketability.
Conclusion
GIGALAB® obtained CE Mark Certification. The certification ensures the organization’s compliance with the European Union’s safety, health, and environmental standards. CE marking also facilitates GIGALAB®’s smooth entry across the European Economic Area (EEA).
