"As part of a transfer of assets during restructuring, the entire operating business was transferred from S&S Scheftner GmbH to Scheftner GmbH. DQS reviewed this transfer, assessed it as non-significant, and confirmed the formal transfer of the certificate.

Our products are currently operating under the transitional arrangements pursuant to Article 120 of the MDR. We have a valid letter of confirmation from our notified body (DQS Medizinprodukte GmbH, identification number 0297) confirming the continued validity of our quality assurance system under the MDD.

This ensures that our products may continue to be placed on the market in compliance with the regulations and that our ability to supply remains guaranteed."