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 1639 due to meeting the requirements of Regulation (EU) 2023/607, the CE certificate GB19/964564 remains valid. 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 CE1639 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 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 |
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 |