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On December 20, 2024, Sola Diagnostics reached another important milestone in the market launch of the WID\u00ae-easy Test, an epigenetic PCR test for the non-invasive detection of endometrial cancer.<\/p>\n
The WID\u00ae-easy PCR Test Kit has received marketing authorization for Great Birtain through registration of the device with the Medicines and Healthcare products Regulatory Agency (MHRA) and confirmation that the WID\u00ae-easy PCR Kit, manufactured by Sola Diagnostics GmbH, meets all applicable regulatory requirements under the UK Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) (UK MDR 2002).<\/p>\n
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The WID-easy PCR Kit is self-certified in accordance with Part IV of the UK MDR 2002, Annex III Sections 1-5 (as amended by Part III of Annex 2A of the UK MDR 2002).<\/p>\n
The following harmonized standards and technical specifications have been applied:<\/p>\n
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The WID-easy PCR kit therefore meets all the necessary safety and performance standards.<\/p>\n
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