FDA.report

FEMASYS INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30078009063007800906FEMASYS INC.1N2026-01-013950 Johns Creek Court Ste 100 Suwanee GA US 30024

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1067341282147514K243114SQA-iOw Sperm Quality AnalyzerPOV2025-05-02
1067341743096969K241693FemChec Controlled Saline-Air Device (FCD-250)LKF2024-09-06
1067341924002971K231730FemaSeed Intratubal InseminationMQF2023-09-22
1067341021882860K122658FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009PCF2012-12-20
1067341229264486K110993FEMCHEC PRESSURE MANAGEMET DEVICELKF2011-10-12
1067341284756816K110288FEMVUE SALINE-AIR DEVICELKF2011-04-28
1067341959636826K100662FEMVUE CORNUAL BALLOON CATHETERLKF2010-04-07
1067341635624940K023222ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12MQL2002-12-26
1067341857102831

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LKF42024-09-06
POV12025-05-02
MQF12023-09-22
PCF12012-12-20
MQL12002-12-26

PMN

GUDID