Our Certifications

EN ISO 374

EN 420

EN 455

ISO 13485

FDA 510(k)




Others :

Classification / Regulatory Compliance / Standards

- ASTM D6319

- EN 1186

- EC, MD Class 1 Dir.93/42/EEC

- FDA 21 CFR 177.2600

- Category III PPE Regulation (EU) 2016/425

- Class I MDR 2017/745