Identity
- Trade Name
- LensHooke Semen Quality Analyzer FDA UDI
- Generic Name
- Spermatozoa/semen analyser IVD FDA UDI
- Model / Reference
- UL-US-X1.E206 FDA UDI
Identifiers
- Catalog Number
- X1 PRO FDA UDI
- Primary DI / UDI-DI
- 04719874741303 FDA UDI
- 510(k) Number
- K202089 FDA UDI
- FDA Product Code
- POV FDA UDI
- GMDN Term
- Spermatozoa/semen analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Spermatozoa/semen analyser IVD
LensHooke Semen Quality Analyzer by Bonraybio Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spermatozoa/semen analyser IVD.
- SQA-Vision Sperm Quality Analyzer — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. · Class II
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- SQA-iOw Sperm Quality Analyzer — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. · Class II
- Unitron — Unitron Hearing · Class II
- SQA-V Sperm Quality Analyzer — M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. · Class II
- Unitron — Unitron Hearing · Class II
- IVOS — HAMILTON THORNE, Inc. · Class II
Cleared under the same submission
K202089 also covers:
- LensHooke Cleaning Wipe — BONRAYBIO CO., LTD.
- LensHooke Cleaning Wipe — BONRAYBIO CO., LTD.
- LensHooke Cleaning Wipe — BONRAYBIO CO., LTD.
- LensHooke Cleaning Wipe — BONRAYBIO CO., LTD.
- LensHooke Semen Quality Analyzer — BONRAYBIO CO., LTD.
- LensHooke Semen Quality Analyzer — BONRAYBIO CO., LTD.
- LensHooke Semen Test Cassette — BONRAYBIO CO., LTD.
- LensHooke Semen Test Cassette — BONRAYBIO CO., LTD.
- LensHooke semen Test Cassette — BONRAYBIO CO., LTD.
- LensHooke semen Test Cassette — BONRAYBIO CO., LTD.
- LensHooke semen Test Cassette — BONRAYBIO CO., LTD.
- LensHooke semen Test Cassette — 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 ed2b3427-2ec4-4eb8-9076-d8a70f912c42 34 fields · synced Jun 1, 2026