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 1639. 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 :-
- moorLDI2-BI Laser Doppler Burns Imager
- moorLDLS-BI Laser Doppler 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|
|moorLDI2-BI Laser Doppler Burns Imager||K060976|
|moorLDLS-BI Laser Doppler Burns Imager||K132163|