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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.
Medical Devices
| Device | Region of Sale | Medical Device CE Marking | FDA 510(k) | Lab Equipment CE Marking |
|---|---|---|---|---|
| moorLDI2-BI | Worldwide | Yes – Class IIa | Yes (K060976) | No |
| moorLDLS-BI | Worldwide | Yes – Class IIa | Yes (K132163) | No |
| moorFLPI-2 | Worldwide | Yes – Class IIa | Yes (K122943) | No |
| MS2-MKII | Worldwide excluding USA | Yes – Class I | No | No |
| MS3B-FLPI-H | Worldwide excluding USA | Yes – Class I | No | No |
| MS3B-LDLS-F | Worldwide excluding USA | Yes – Class I | No | No |
| MS3B-LDLS-H | Worldwide excluding USA | Yes – Class I | No | No |
| MS4 | Worldwide excluding USA | Yes – Class I | No | No |
| moorLDI2-VR | Worldwide excluding EU & UK | No | Yes (K152749) | No |
| moorLDI2-IR | Worldwide excluding EU & UK | No | Yes (K152749) | No |
| moorLDI2-HIR | Worldwide excluding EU & UK | No | Yes (K152749) | No |
| BS1 | Worldwide excluding EU, UK, & USA | No | No | No |
| DS2 | Worldwide excluding EU, UK, & USA | No | No | No |
| moorVMS-LDF | Worldwide excluding EU & UK | No | Yes (K083082) | No |
| moorVMS-PRES | Worldwide excluding EU & UK | No | Yes (K102433) | No |
| moorVMS-OXY | Worldwide excluding EU & UK | No | Yes (K112826) | No |
| moorVMS-NIRS | Worldwide excluding EU, UK, & USA | No | No | No |
| moorVMS-HEAT | Worldwide excluding EU, UK, & USA | No | No | No |
| moorVMS-ION | Worldwide excluding EU, UK, & USA | No | No | No |
| moorVMS-PC | Worldwide excluding EU, UK, & USA | No | No | No |
Note: Worldwide sale is subject to compliance with local regulatory requirements.
Laboratory Equipment – non medical use only
| Device | Region of Sale | Medical Device CE Marking | FDA 510(k) | Lab Equipment CE Marking |
|---|---|---|---|---|
| moorLDI2-VR-EU | EU & UK Only | No | No | Yes |
| moorLDI2-IR-EU | EU & UK Only | No | No | Yes |
| moorLDI2-HIR-EU | EU & UK Only | No | No | Yes |
| BS1-EU | EU & UK Only | No | No | No* |
| DS2-EU | EU & UK Only | No | No | No* |
| moorO2Flo-2 | Worldwide | No | No | Yes |
| moorLAB-LDF | EU & UK Only | No | No | Yes |
| moorLAB-PRES | EU & UK Only | No | No | Yes |
| moorLAB-OXY | EU & UK Only | No | No | Yes |
| moorLAB-NIRS | EU & UK Only | No | No | Yes |
| moorLAB-HEAT | EU & UK Only | No | No | Yes |
| moorLAB-ION | EU & UK Only | No | No | Yes |
| moorLAB-NIBP | Worldwide | No | No | Yes |
| moorLAB-PC | EU & UK Only | No | No | No* |
Note: Worldwide sale is subject to compliance with local regulatory requirements.
*There are no relevant EU directives or regulations for these devices.