Identity
- Trade Name
- LensHooke semen Test Cassette FDA UDI
- Generic Name
- Microscope counting chamber IVD FDA UDI
- Model / Reference
- CS1_200pcs_HT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 44719874741158 FDA UDI
- 510(k) Number
- K202089 FDA UDI
- FDA Product Code
- POV FDA UDI
- GMDN Term
- Microscope counting chamber 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Microscope counting chamber IVD
LensHooke semen Test Cassette by Bonraybio Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Microscope counting chamber IVD.
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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 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.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bonraybio Co., Ltd.
Sources (1)
- FDA UDI 65b1ab70-6e66-44c5-85f2-2301af63e6d6 33 fields · synced May 30, 2026