ISO 13485 Certified Quality Management System

TannerMedico A/S holds ISO 13485 certificate no. 8009, confirming that its quality management system is certified to ISO 13485:2016 by UDEM Adriatic d.o.o.

  • Certificate number: 8009
  • Certification decision date: 14 November 2025
  • Valid until: 13 November 2028

View and download TannerMedico’s ISO 13485:2016 certificate (PDF)

Certification scope:
Design and Development and Distribution as the Legal Manufacturer of a Non-Sterile Nasal Spray Medical Device (Asonor).

The ISO 13485 certificate relates to TannerMedico A/S’s quality management system. It does not constitute certification of Asonor as a product and is separate from MDR product conformity assessment.

Medical Device Regulatory Information

Asonor® Anti-Snoring Solution is a non-sterile medical device for which TannerMedico A/S is the legal manufacturer.

  • Device: Asonor® Anti-Snoring Solution, 30 ml
  • EU classification: Class IIa under Regulation (EU) 2017/745, Rules 5 and 21
  • Basic UDI-DI: 5703562001007V4
  • UDI-DI: 05703562001007
  • Single Registration Number: DK-MF-000038973

Product information and instructions for use are maintained as controlled documents and made available in accordance with applicable regulatory requirements.

Regulatory Contact

For quality or regulatory enquiries, please contact TannerMedico A/S at [email protected].