Lapis Lazuli develops and manufactures Medical Devices under the applicable European Guidelines (MEDDEV 93/42/EEC) and current quality standards;
CE Full Quality Certification
CE Full Quality Certification that certifies the quality system implemented in the company is under ISO regulations 9001 and 13485. CE Product certification that certifies the compliance of the product with the applicable requirements under the European Directive 93/42/EEC and other EN standards.
Owing to the classification of the product as Class IIb, the certifications are issued by the corresponding European Notify Body (CE0473 and CE0344).