Ámbitos del certificado

• EN ISO 13485
  

  Design and development, production and distribution of rehabilitation devices for laryngectomized and tracheotomized patients as well as accessory devices for wound care.

• MDD Annex II excl. 4
  

  Medical devices for tracheostoma care

  Replaces EC-Certificate, Registration No.: HD 60145542 0001

  Products included:

  - Tracheal cannula with/without cuff
  - Airway maintenance clips
  - Heat moisture exchangers/HMEs with O2 connection
  - Speaking valves with O2 connection
  - Disinfection solutions

• MDD Annex V
  

  oxygene connecting tubes

• MDR Ann. IX, Chapt I
  

  Products of class I, sterile:
  - R010580 - Tracheostomy and Laringectomy Cannulas - Accessories

  The scope of certification is limited to the aspects relating to establishing, securing and maintaining

  Products of class IIa:
  - R010580 - Tracheostomy and Laringectomy Cannulas - Accessories
  - V030299 – Dimensional Clinical Parameters Measuring Devices - Other

  Products of class IIb
  Tracheostomy and Laringectomy Cannulas
  - R010501 - Tracheostomy and Laringectomy Cannulas and Kits, Uncuffed
  - R010502 - Tracheostomy and Laringectomy Cannulas and Kits, Cuffed
  - R010503 - Tracheostomy Inner Cannulas