On 19th July 2018 our lead product Bella-mu | the intradermic needle, was approved for marketing in Europe! This milestone for the company means Bella-mu is now available for use in European clinics for any intradermal injection. Please contact us if you would like to discuss the use of our intradermic needles in your clinical trial.
Rights were granted for the entire product category Silicon microneedle for intradermal use based on the full quality assurance system quality route U-Needle implemented:
For the product category Silicon microneedle for intradermal use DEKRA grants the right to use the EC Notified Body Identification Number 0344 to accompany the CE Marking of Conformity on the products concerned conforming to the required Technical Documentation and meeting the provisions of the EC-Directive 93/42/EEC on Medical devices, Annex II excluding (4), being Devices in Class IIa, IIb or III