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FemaSeed Intratubal Insemination
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref FDI-200
by Femasys Inc.
Identity
- Trade Name
- FemaSeed Intratubal Insemination EUDAMEDFemaSeed FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Device Name
- FemaSeed Intratubal Insemination EUDAMEDFemaSeed Intratubal Insemination, FDI-200, 5-Pack FDA UDI
- Model / Reference
- FDI-200 EUDAMEDFDA UDI
- Description
- FemaSeed Intratubal Insemination, FDI-200, 5-Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30859500005104 EUDAMEDFDA UDI
- Basic UDI-DI
- 00859500005FDIN3 EUDAMED
- 510(k) Number
- K231730 FDA UDI
- FDA Product Code
- MQF FDA UDI
- EMDN Code
- U08020101 CATHETERS FOR INSEMINATION EUDAMED
- GMDN Term
- Assisted reproduction transfer catheter/set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6110 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
FemaSeed Intratubal Insemination 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 | K231730 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 00859500005FDIN3 | Class I | Active |
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Manufacturer
- Manufacturer
- Femasys Inc.
- EUDAMED SRN
- US-MF-000009888
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED de273070-a816-4c5b-acd1-700dd91ea228 61 fields · synced Jul 18, 2026
- FDA UDI e733c441-3148-4691-ac57-f644a448f297 34 fields · synced May 30, 2026
- FDA 510(k) K231730 1 fields · synced May 18, 2026