June 2022 - Isohelix

Isohelix Registers it’s Devices on EUDAMED Under New MDR 2017/745 & IVDR 2017/746 Registrations

Posted on 20 June 202221 November 2023 by Alister Seaton

Isohelix has registered its ‘GeneFix DNA/RNA Collectors’ and ‘Isohelix DNA/RNA Buccal Swabs’ to meet our registration obligations under the new MDR 2017/745 and IVDR 2017/746.

Isohelix Initiates the Full IVD/Medical Device Registration of its Buccal and Saliva Collectors in Switzerland

Posted on 17 June 202221 November 2023 by Alister Seaton

Isohelix is pleased to announce that it has engaged ‘AJW Technology’ as the Swiss Representative for the ‘GeneFiX DNA/RNA Collectors’ and ‘Isohelix DNA/RNA Buccal Swabs’ to ensure a smooth device registration and supply of these products into the Swiss market.

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