---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-008559"
form_type: "8-K"
ticker: "FEMY"
cik: "0001339005"
company_name: "FEMASYS INC"
filed_at: "2025-03-13T23:59:59+00:00"
generated_at: "2026-05-24T20:38:01.259265+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Femasys gets CE mark for FemBloc delivery system in Europe, polymer approval expected mid-2025

## Summary
- FemBloc delivery system receives first-in-world CE mark certification under EU MDR for non-surgical permanent birth control.
- FemBloc blended polymer completes G12 Special MDR Audit; Notified Body recommends CE mark pending EMA review, approval expected mid-2025.
- Company continues enrolling participants in FDA IDE-approved pivotal clinical trial for U.S. approval of FemBloc.
- CEO Kathy Lee-Sepsick highlights FemBloc as a safer, accessible alternative to surgical sterilization, the only option today.

## SEC filing metadata
- accession: 0001140361-25-008559
- form_type: 8-K
- ticker: FEMY
- cik: 0001339005
- company_name: FEMASYS INC
- filed_at: 2025-03-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1339005/000114036125008559/0001140361-25-008559-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1339005/000114036125008559/ef20045446_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-008559
- JSON: https://secwatch.observer/filing/0001140361-25-008559.json
- Plain text: https://secwatch.observer/filing/0001140361-25-008559.txt

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