12.03.2025 |

Product Change from European IVDD to IVDR on in vitro diagnostic medical devices

FUJIFILM Waka Chemicals Europe GmbH would like to inform all of our customers about the upcoming change from IVDD products to IVDR compliant products.

This transition will take place in 2025 and concerns all lVD products manufactured by FUJIFILM Wako Chemicals Europe GmbH, listed below in alphabetically order:

• Autokit 3-HB Assay
• Autokit CH50 Assay
• Autokit Total Ketone Bodies Assay
• Direct Bilirubin L-Type Assay
• HDL-C L-Type Assay
• Hyaluronic Acid LT Assay
• LDL-C L-Type Assay
• NEFA-HR{2) Assay
• Total Bilirubin L-Type Assay

This transition will have no change on production site nor on the quality and performance of the above mentioned IVD products. There will only be a regulatory change of legal manufacturer for the above mentioned IVD products. FUJIFILM Wako Pure Chemical Corporation will be Legal Manufacturer for the IVDR compliant products, with FUJIFILM Wako Chemicals Europe GmbH as European Authorized Representative and Importer. The products will be available as IVDD products and IVDR products in parallel for a limited time.

	Manufacturer of IVDD products	Manufacturer of IVDR products
Names	FUJIFILM Wake Chemicals Europe GmbH	FUJIFILM Wake Pure Chemical Corporation
Address	Fuggerstr. 12, 41468 Neuss, Germany	1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan

 

FUJIFILM Wake will continue to provide high quality products under IVDR and encourage you to contact us if you have any questions.