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Standards & Approvals

It is our policy to design and manufacture equipment of the highest quality and reliability to meet the requirements of our customers. Moor Instruments has been assessed and certified as meeting the requirements of ISO13485:2003 by the Standards Council of Canada Accredited Registrar, ISO13485:2003 by UKAS Management Systems Accredited Registrar 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.

Moor Instruments FDA 510(k) registered products

The following Moor Instruments products are registered with the FDA (Food and Drug Administration) :-

  • DRT4 - 510(k) Number K011070
  • moorLDI - 510(k) Number K980383
  • moorLDI-IR - 510(k) Number K032841
  • moorLDI2-BI - 510(k) Number K060976
  • moorLDLS - 510(k) Number K063561
  • moorLDLS-BI - 510(k) Number K132163
  • moorFLPI - 510(k) Number K063586
  • moorFLPI-2 - 510(k) Number K122943
  • moorVMS-LDF1 & moorVMS-LDF2 - 510(k) Number K083082
  • moorVMS-PRES - 510(k) Number K102433
  • moorVMS-OXY - 510(k) Number K112826

Moor Instruments licensed Health Canada products

The following Moor Instruments products are licensed by Health Canada :-

  • moorVMS-LDF Family Licence No. 97013

The moorVMS-LDF family consists of the following:

moorVMS-LDF1
moorVMS-LDF1-HP
moorVMS-LDF2

  • moorLDI2-BI Licence No. 75477
  • moorFLPI Licence No. 80750
  • moorLDI2 Family Licence No. 79095

The moorLDI2 family consists of the following:

moorLDI2-IR
moorLDI2-VR
moorLDI2-HIR