---
schema_version: "secwatch.filing_event.v1"
accession: "0001161697-24-000196"
form_type: "8-K"
ticker: "KRMD"
cik: "0000704440"
company_name: "KORU Medical Systems, Inc."
filed_at: "2024-04-11T23:59:59+00:00"
generated_at: "2026-06-04T00:13:19.112831+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# KORU Medical wins EU notified body appeal, CE certification continues uninterrupted

## Summary
- 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.

## SEC filing metadata
- accession: 0001161697-24-000196
- form_type: 8-K
- ticker: KRMD
- cik: 0000704440
- company_name: KORU Medical Systems, Inc.
- filed_at: 2024-04-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/704440/000116169724000196/0001161697-24-000196-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/704440/000116169724000196/form_8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001161697-24-000196
- JSON: https://secwatch.observer/filing/0001161697-24-000196.json
- Plain text: https://secwatch.observer/filing/0001161697-24-000196.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.