Standards & Approvals

It is our policy to design and manufacture medical and life science equipment of the highest quality and reliability to meet the requirements of our customers.

Moor Instruments in the design and manufacture of medical devices has been assessed and certified as meeting the requirements of ISO13485:2016 and Directive 93/42/EEC by Notified Body 0120. By working to strict quality control procedures, we ensure product safety and reliability.

Moor Instruments CE marked products

All commercially available products are CE (European Conformity) marked.

The following products are registered with the Notified Body and CE0120 marked :-

  • moorVMS-LDF Laser Doppler Perfusion and Temperature Monitor
  • moorVMS-OXY Tissue Oxygen and Temperature Monitor
  • moorVMS-NIRS Near-Infrared Oxygenation Monitor
  • moorVMS-PRES Vascular Assessment Pressure Cuff Controller
  • moorVMS-HEAT Skin Heater and Temperature Monitor
  • moorVMS-TREND PC Software
  • moorVMS-VASC PC Software
  • moorVMS-PC PC Software
  • moorLDI2 Laser Doppler Imager
  • moorLDLS2 Laser Doppler Line Scanner
  • moorFLPI-2 Full-field Laser Perfusion Imager
  • moorLDI2-BI Laser Doppler Burns Imager
  • moorLDLS-BI LaserDoppler Burns Imager

Moor Instruments USA FDA 510(k) registered products

The following Moor Instruments products are registered with the USA FDA (Food and Drug Administration) under a 510(k) premarket submission:-

Device Name 510(K) Number
moorVMS-LDF1, moorVMS-LDF2 and moorVMS-LDF1-HP Laser Doppler Perfusion and Temperature Monitor K083082
moorVMS-OXY Tissue Oxygen and Temperature Monitor K112826
moorVMS-PRES Vascular Assessment Pressure Cuff Controller K102433
moorLDI2-IR Infrared Laser Doppler Imager
moorLDI2-HIR High Resolution Infrared Laser Doppler Imager
moorLDI2-VR Visible Red Laser Doppler Imager
K152749
moorLDLS Laser Doppler Line Scanner K063561
moorFLPI-2 Full-field Laser Perfusion Imager K122943
moorLDI2-BI Laser Doppler Burns Imager K060976
moorLDLS-BI Laser Doppler Burns Imager K132163
moorFLPI Full-field Laser Perfusion Imager K063586
moorLDI Laser Doppler Imager K980383
moorLDI-IR Infrared Laser Doppler Imager K032841
DRT4 Laser Doppler Perfusion and Temperature Monitor K011070