Identity
- Trade Name
- LensHooke Sperm Separation Device FDA UDI
- Generic Name
- Sperm filtration system FDA UDI
- Model / Reference
- CA1 Package-150 sets-US-BR FDA UDI
Identifiers
- Catalog Number
- CA1 FDA UDI
- Primary DI / UDI-DI
- 24719874742281 FDA UDI
- 510(k) Number
- K221810 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
Yes
FDA UDI
Category: Sperm filtration system
LensHooke Sperm Separation Device by Bonraybio Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SpermAlign — Cytoswim, Ltd. · Class II
- MDHC — MDHC Life Technologies (Kunshan) Co., LTD. · Class I
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD. · Class II
Cleared under the same submission
K221810 also covers:
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD.
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD.
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD.
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD.
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD.
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD.
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD.
- LensHooke Sperm Separation Device — BONRAYBIO CO., LTD.
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
- Bonraybio Co., Ltd.
Sources (1)
- FDA UDI 00d365eb-c3a9-43f1-b2da-25fd9033315f 34 fields · synced May 30, 2026