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Disposable Surgical Facemask Type IIR/MDR* approval

mahe medical service gmbh produces Disposable Surgical Facemask Type IIR 100% Made in Germany at the plant location in Emmingen.

Your advantages Made in Germany:

  • Savings in freight cost
  • Savings in warehousing
  • Short delivery time
  • Produced by mahe medical service gmbh Made in Germany 
    -> factory location Emmingen
  • CE approved

Advantages of our surgical masks:

  • An extended nose clip prevents fogging of glasses.
  • Nonwovens with a pleasant, breathable material ensure a very high level of comfort.
  • The masks are focused on avoiding skin irritation and are conceived for being worn for relatively long time.
  • Very soft cuff to avoid pressure points even after prolonged use.

*What does MDR approval mean?

The new Medical Device Regulation (MDR) of the EU regulates the requirements for the development, manufacture, use and monitoring of medical devices. In particular, it establishes uniform criteria for the certification of medical devices and regulates the procedure for the approval of clinical trials of medical devices, thus expanding the obligations for manufacturers. 

The new regulations of the Medical Device Regulation (MDR) include, among other things, that a quality management system must be proven, unannounced audits are carried out, tightened provisions for market surveillance and improved identification and traceability of medical devices through a unique ID number.

For you as a customer, this means even greater safety for medical devices and the highest possible quality standards with consistent quality every time.