regulatory
confidence high
sentiment positive
materiality 0.60
KORU Medical wins EU notified body appeal, CE certification continues uninterrupted
KORU Medical Systems, Inc.
- BSI had recommended against continued certification after March 2024 audit nonconformance.
- Appeal upheld April 8, 2024; no suspension or interruption of EU product sales.
- Products remain certified, marketed, and sold in EU; proceeds through routine BSI assessment.
- CEO Linda Tharby cites swift team response and positive BSI interaction.