FDA Registration
Active
🇺🇸 United States
FEMASYS INC.
Reg #: 3007800906
·
FEI: 3007800906
·
Expires 2026
Products
6
Proprietary Names
9
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- FEMASYS INC.
- Registration Number
- 3007800906
- FEI Number
- 3007800906
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3950 Johns Creek Court, Ste 100
- City
- Suwanee
- State
- GA
- ZIP
- 30024
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110288
Owner / Operator
- Firm Name
- Femasys Inc.
- Operator Number
- 10030021
- Address
- 3950 Johns Creek Court, Suite 100
- City
- Suwanee
- State
- GA
- Postal Code
- 30024
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2011-11-07 |
| Semen Analysis Device | POV | Class 2 | Hematology | No | 2026-01-26 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2023-05-15 |
| Sampler, Endocervical | PCF | Class 2 | Obstetrics/Gynecology | No | 2013-01-07 |
| Media, Reproductive | MQL | Class 2 | Obstetrics/Gynecology | No | 2026-01-26 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2023-09-28 |
Proprietary Names
FemVue
FemChec Controlled Saline-Air Device
FemSperm Analyzer
FemCath Cornual Balloon Catheter
VariLock Balloon Inflation Syringe
StopLock Balloon Inflation Syringe
FemCerv¿
FemSperm
FemaSeed Intratubal Insemination
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198