Identity
- Trade Name
- SpermAlign FDA UDI
- Generic Name
- Sperm filtration system FDA UDI
- Device Name
- SpermAlign is a passive microfluidic device that separates sperm based on their motility. Separation is achieved through a defined microstructure which guides the motile sperm to the central collection outlet isolating it from the remaining sample. The device utilises a total processing volume of 180ul of liquefied semen added in 30ul aliquots to each of the six outer wells and with media added to the central well. Following incubation for 30 minutes, the concentrated motile sperm is withdrawn from the central well and may be used directly in the respective procedure. FDA UDI
- Model / Reference
- CYT 001 FDA UDI
- Description
- SpermAlign is a passive microfluidic device that separates sperm based on their motility. Separation is achieved through a defined microstructure which guides the motile sperm to the central collection outlet isolating it from the remaining sample. The device utilises a total processing volume of 180ul of liquefied semen added in 30ul aliquots to each of the six outer wells and with media added to the central well. Following incubation for 30 minutes, the concentrated motile sperm is withdrawn from the central well and may be used directly in the respective procedure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15070002516207 FDA UDI
- 510(k) Number
- K232980 FDA UDI
- FDA Product Code
- MQK FDA UDI
- GMDN Term
- Sperm filtration system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Category: Sperm filtration system
SpermAlign by Cytoswim, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cytoswim, Ltd.
Sources (1)
- FDA UDI 479f8741-440d-4d4d-a321-42afb0c742bc 35 fields · synced Jun 8, 2026