{"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","discovered_at":"2026-05-14T18:03:21.718548+00:00","generated_at":"2026-06-04T00:13:19.112831+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"KORU Medical wins EU notified body appeal, CE certification continues uninterrupted","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001161697-24-000196","json":"https://secwatch.observer/filing/0001161697-24-000196.json","markdown":"https://secwatch.observer/filing/0001161697-24-000196.md","text":"https://secwatch.observer/filing/0001161697-24-000196.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T00:13:19.112831+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}