---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-24-030638"
form_type: "8-K"
ticker: "FEMY"
cik: "0001339005"
company_name: "FEMASYS INC"
filed_at: "2024-06-20T23:59:59+00:00"
generated_at: "2026-06-01T03:16:55.840746+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Femasys receives CE Mark for four women's health products, enters EU market

## Summary
- Received EU MDR certificate and CE Mark for FemaSeed, FemVue, FemCerv, FemCath.
- Approvals allow Femasys to begin marketing all four products in the European Union.
- CEO Kathy Lee-Sepsick: CE Mark validates commitment to highest quality and safety standards.
- Company will identify strategic distribution partners to commercialize products throughout the EU.
- Initial US commercial team build-out completed; EU expansion follows CE Mark approval.

## SEC filing metadata
- accession: 0001140361-24-030638
- form_type: 8-K
- ticker: FEMY
- cik: 0001339005
- company_name: FEMASYS INC
- filed_at: 2024-06-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1339005/000114036124030638/0001140361-24-030638-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1339005/000114036124030638/ef20031386_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-24-030638
- JSON: https://secwatch.observer/filing/0001140361-24-030638.json
- Plain text: https://secwatch.observer/filing/0001140361-24-030638.txt

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