Certificates

ISO 13485:2016 CertificateExpiry date: 2026-05-22
Directive 98/79/EC Certificate Expiry date: 2025-05-26*

*Please note:

As of August 16th, 2022 imusyn has withdrawn the recombinant Blood Group Antigen (rBGA) Reagents from the scope of EC Certificate 0197/HL1381718-1. Our rBGA are available for Research Use Only (RUO).

The EC certificate cannot be extended. imusyn has received a Confirmation Letter in accordance with Regulation (EU) 2024/1860. This letter was issued on May 22, 2025, by TÜV Rheinland LGA Products GmbH, a Notified Body designated under Regulation (EU) 2017/746 (IVDR) and identified by number 0197 in the NANDO database.
The transition timelines applicable to the devices covered by this letter - provided imusyn continues to meet the other conditions outlined in Article 110(3c) of the IVDR, as amended by Regulation (EU) 2024/1860 - are as follows: December 31, 2027.