About us
We are a UK medical device developer and distributor based at Wrexham University’s OpTIC Technology Centre in North Wales. For over 20 years we have been providing hospital and medical research laboratories with quality assured diagnostics, and are engaged in research projects with UK universities and the NHS to develop new tests for use on the ward.
Our aim is to provide our customers with reliable, regulated medical tests and professional technical support, ensuring that the tests you use at home meet the same rigorous standards as those used in a hospital setting.
Preliminary health screening and self-testing
SELFCHECK® medical self-testing devices are manufactured exclusively for us in France by VEDALAB, and distributed in the UK by our consumer health division, 1st Health Products Ltd., owned by UK based medical diagnostics company J R Biomedical Ltd., established in 2005.
Self-testing provides a preliminary screen of physiological biomarker levels, and whether positive or negative, a self-test result can be a starting point for a conversation about your symptoms with your doctor - but it is not a diagnosis. If you are concerned about your symptoms, or anxious about your health, always speak with an appropriate healthcare professional. Find out more about the limitations of self-testing.
Quality assurance
As we develop and distribute clinical products, our R&D, device assembly and distribution facility in North Wales is certified and audited to ISO 13485:2016 - the internationally recognised standard for medical device quality assurance. All our medical SELFCHECK tests are CE certified and registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA) specifically for self-testing.
Professional customer care when you need it
With 20 years experience and expertise developing new medical diagnostics for use in the hospital laboratory as well as for self-testing, we provide prompt support if you need any help to understand how your test works.
Information for healthcare professionals
We have created a separate section on our website specifically for healthcare professionals with clinician guides for each of our self-testing devices. For our range of clinical and research diagnostics, or to discuss how we can help commercialise your research, please visit our healthcare professional site.
Information for journalists
Information on how self-testing kits are evaluated and regulated in the UK is available for journalists.
References
1) NHS Clinical Evaluation Team - Clinical Review For Blood Lancets. Sept 2018
UNISTIK® and Comfort Zone Technology™ are trademarks of Owen Mumford Ltd.