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Femasys, Inc.

USA · Suwanee

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 0Class II 6Class III 0

plus 8 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 2

11 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIa 1Class Is (sterile) 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States8 registration records, 9 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: FEMASYS INC.

Business registration

Legal name: FEMASYS INC
CIK: 0001339005
Registration status: Active
Listing status: Listed (FEMY)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12009

12010

22011

12012

12023

22024

12025

FDA listed device types

Catheter, Assisted Reproduction 1Media, Reproductive 1Semen Analysis Device 1Sampler, Endocervical 1Cannula, Manipulator/Injector, Uterine 1Syringe, Balloon Inflation, Exempt 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253403	FemVue® Controlled Saline-Air Device (FSA-300)	2025-12-15
US	K242002	FemVue MINI Saline-Air Device	2024-11-22
US	K241693	FemChec Controlled Saline-Air Device (FCD-250)	2024-09-06
CA	87262	FEMVUE SALINE-AIR DEVICE	Class II
CA	87816	HSG CATHETER 5F, FIRM	Class II

Femasys, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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