Lodestar DX is brought to the UK market through a partnership between two specialist organisations.
Manufacturer
Llusern Scientific Ltd is a UK manufacturer of molecular diagnostic testing systems. Lodestar DX is Llusern's proprietary testing platform and is UKCA-marked, ISO 13485:2016 certified (BSI MD 812652), and registered with the MHRA (GMDN 64635). Lodestar is a registered trademark of Llusern Scientific Ltd.
UK Distributor
Syner-Med (Pharmaceutical Products) Ltd is a UK-based specialty pharmaceutical and medical device distributor with a focus on urology, women's health and bladder care. Syner-Med holds the UK distribution rights for Lodestar DX, with commercial responsibility for clinical evaluations, post-launch support, and adverse incident reporting in the UK market.
Regulatory
Lodestar DX is UK Conformity Assessed and approved for sale in Great Britain as an in vitro diagnostic medical device.
Llusern Scientific maintains ISO 13485:2016 certification for the design and manufacture of medical devices. Certificate number BSI MD 812652.
Llusern Scientific Ltd is registered with the UK Medicines and Healthcare products Regulatory Agency. Lodestar DX is registered under GMDN code 64635.
Adverse incidents
Adverse incidents relating to Lodestar DX should be reported to PV@syner-med.com and via the MHRA Yellow Card scheme. Refer to the Lodestar DX Instructions for Use for full safety and operational guidance.
For commercial, clinical and partnership enquiries, contact the Syner-Med team.