← Back to catalogue
FemChec Controlled Saline-Air Device
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref FCD-250
by Femasys Inc.
Identity
- Trade Name
- FemChec Controlled Saline-Air Device EUDAMEDFemChec FDA UDI
- Generic Name
- Uterine injector FDA UDI
- Device Name
- FemChec Controlled Saline-Air Device EUDAMEDFemChec Controlled Saline-Air Device, FCD-250 Bulk Sterile FDA UDI
- Model / Reference
- FCD-250 EUDAMEDFDA UDI
- Description
- FemChec Controlled Saline-Air Device, FCD-250 Bulk Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859500005097 EUDAMEDFDA UDI
- Basic UDI-DI
- 00859500005FCDMN EUDAMED
- 510(k) Number
- K241693 FDA UDI
- FDA Product Code
- LKF FDA UDI
- EMDN Code
- A03010299 IRRIGATION CONTROLLERS - OTHER EUDAMED
- GMDN Term
- Uterine injector FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
FemChec Controlled Saline-Air Device by Femasys Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K241693 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 00859500005FCDMN | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Femasys Inc.
- EUDAMED SRN
- US-MF-000009888
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED d98656b6-4447-46db-b0da-96b5c76edfa5 61 fields · synced Jun 19, 2026
- FDA UDI 433aaeb5-2159-412e-8227-29d722d4692f 34 fields · synced May 30, 2026
- FDA 510(k) K241693 1 fields · synced May 18, 2026