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FemVue Saline-Air Device
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref FSA-205IWModel FSA-200510(k) K110288
by Femasys Inc.
Identity
- Trade Name
- FemVue Saline-Air Device EUDAMED
- Device Name
- FemVue Saline Air Device EUDAMED
- Model / Reference
- FSA-200 EUDAMEDFSA-205IW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10859500005001 EUDAMED
- Basic UDI-DI
- 00859500005FSANY EUDAMED
- EMDN Code
- U080102 CATHETERS FOR HYSTEROSALPINGOGRAPHY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
FemVue Saline-Air Device by Femasys Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110288 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 00859500005FSANY | Class I | Active |
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Manufacturer
- Manufacturer
- Femasys Inc.
- EUDAMED SRN
- US-MF-000009888
- FDA Applicant
- Femasys, Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3de81057-9623-4729-8cff-019d60bbbb8a 85 fields · synced Jun 18, 2026
- FDA 510(k) K110288 1 fields · synced May 18, 2026