Important Information

MASK:

  • Certified to BS EN 14683:2019 and EN 14683:2019+AC:2019 (includes testing to BS EN ISO 10993-1:2009, BS EN ISO 11737-1:2018, ISO 22609:2004).
  • MDR compliant (EU 2017/745).
  • Registered as a Class 1 Medical Device with MHRA
  • CE Marked

FULFILMENT:

  • Packaged in ISO 8 Cleanroom environment. Compliant to BS EN 14644-1:2015 including BS EN 14644-2:2015, BS EN 14644-3:2019, BS EN 14644-4:2001, BS EN 14644-5:2004, BS EN 14644-6:2007, BS EN 14644-8:2013, BS EN 14644-9:2012, BS EN 14644-10:2013, BS EN 14644-13:2017, BS EN 14644-14:2016, BS EN 14644-15:2017, BS EN 14644-16:2019, with document 19/30385895 (BS EN 14644-17) taken into consideration

PACKAGING:

  • 100% recyclable, printed using Eco-friendly (vegetable based) inks.
  • MD Manufacturer Information compliant with BS EN 1041:2008+A1:2013, EN ISO 15223-1:2016 (ISO 15223-1:2106, corrected version 2017-03).

BARCODING & TRACEABILITY:

  • GS1 128 Barcoding (Manufacturer GTIN, manufacture date, expiration date, Batch and Serial number), full ‘Part’ and ‘component’ traceability software.
  • REACH compliant