secwatch.observer — SEC 8-K summary
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Issuer:     KORU Medical Systems, Inc. (KRMD)
CIK:        0000704440
Form:       8-K
Filed at:   2024-04-11T23:59:59+00:00
Accession:  0001161697-24-000196
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/704440/000116169724000196/0001161697-24-000196-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/704440/000116169724000196/form_8-k.htm
  HTML page:      https://secwatch.observer/filing/0001161697-24-000196

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer