---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-023561"
form_type: "8-K"
ticker: "FEMY"
cik: "0001339005"
company_name: "FEMASYS INC"
filed_at: "2025-06-25T23:59:59+00:00"
generated_at: "2026-05-18T19:06:49.248691+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 FemBloc, first non-surgical permanent birth control, for European market

## Summary
- CE mark certification for entire FemBloc System under EU MDR 2017/745; can now be marketed in European Economic Area (27 EU + 3 EFTA states).
- Follows earlier March 13, 2025 delivery system approval; combined approval marks first global regulatory endorsement.
- Company plans initial commercial launch in Spain via existing distribution partnerships; also seeking additional country approvals.
- FemBloc is a non-surgical permanent birth control alternative; U.S. FDA IDE pivotal trial continues enrollment for U.S. approval.

## SEC filing metadata
- accession: 0001140361-25-023561
- form_type: 8-K
- ticker: FEMY
- cik: 0001339005
- company_name: FEMASYS INC
- filed_at: 2025-06-25T23:59:59+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/1339005/000114036125023561/0001140361-25-023561-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1339005/000114036125023561/ef20050990_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-023561
- JSON: https://secwatch.observer/filing/0001140361-25-023561.json
- Plain text: https://secwatch.observer/filing/0001140361-25-023561.txt

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