Penlon ESO 2 Receives UKCA Mark

The Penlon ESO 2 Ventilator, previously known as the Penlon ESO 2 Emergency Ventilator, has received its UKCA mark. UK Clinicians can now use the ESO 2 Ventilator for all suitable patients and not only those suffering from COVID-19 (SARS-CoV-2). This update provides Clinicians in the UK with the option of using the ESO 2 Ventilator on a wider range of patients, whether in the Intensive Care Unit (ICU) or the operating room (OR).

The Penlon ESO 2 Ventilator was certified with a restricted scope of use for the treatment of patients suffering from COVID-19 (SARS-CoV-2) respiratory disease. An increased understanding of the disease and a successful vaccination programme in the UK has resulted in fewer patients requiring invasive ventilation for this condition. With the UKCA mark, Penlon, with the support of their Clinical Advisory Panel, has been able to widen the clinical scope of the ESO 2 so that the 11,683 ventilators that were supplied to the NHS last year can now be used on all suitable patient types and not only those suffering from COVID-19 (SARS-CoV-2). In particular, its use will play a vital role in supporting patients in the ICU and tackling the backlog of semi-elective surgeries in the UK.

Penlon worked closely with a number of clinical specialists, analysists, MD-TEC lab, NHS, DHSC and SGS UK this year and produced the necessary documentation to support the application, which was granted earlier this month.

Penlon is one of the first medical device manufacturers, globally, to receive the UKCA mark.

UKCA Marking

The UKCA (UK Conformity Assessed) marking is a new UK product certification used for goods placed on the market in Great Britain and covers most goods that previously required the CE certificate. The UKCA process came into effect on 1 January 2021.  There are currently only 3 Approved Bodies delivering medical device UKCA certificates in the UK; SGS United Kingdom Ltd (0120), BSI UK Assurance Ltd (0086) and UL International (UK) Ltd (0843).