Data / Medical devices / Taiwan / Bonraybio Co., Ltd.
Bonraybio Co., Ltd.: FDA-registered device maker in Taichung, Taiwan, 5 510(k) clearances
Bonraybio Co., Ltd. is registered with the FDA (registration 3014053517) in Taichung, Taiwan. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014053517
- Address
- 4F., No. 118, Gongye 9th Rd., Dali Dist., Taichung, Taiwan, 41280
- Owner or operator
- Bonraybio Co., LTD. (10055998)
- Roles
- Manufacturer
- First device listed
- October 26, 2017
- Registered through
- 2026
- Brand names listed
- C-KUP Liquefaction Test Cup, LensHooke CA0 Sperm Separation Device, LensHooke CA1 Sperm Separation Device, LensHooke Cleaning Wipe CW0; LensHooke Cleaning Wipe CW1, LensHooke Cleaning Wipe CW0; LensHooke Cleaning Wipe CW1; LensHooke Cleaning Wipe Holder CWA, LensHooke Liquefaction Enzyme, LensHooke Prestained Morphology Slide CR0, LensHooke R10 Plus Sperm DNA fragmentation Rapid Test Kit (SCD assay) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen, Non-Sterile | NNI | 1 | Manufacturer | accessdata.fda.gov |
| Counter, Differential Cell | GKZ | 2 | Manufacturer | accessdata.fda.gov |
| Hemocytometer | GHO | 1 | Manufacturer | accessdata.fda.gov |
| Labware, Assisted Reproduction | MQK | 2 | Manufacturer | accessdata.fda.gov |
| Material, Quality Control, Semen Analysis | NRF | 2 | Manufacturer | accessdata.fda.gov |
| Semen Analysis Device | POV | 2 | Manufacturer | accessdata.fda.gov |
| Stains, Hematology | KQC | 1 | Manufacturer | accessdata.fda.gov |
| Trypsin | IBG | 1 | Manufacturer | accessdata.fda.gov |
| Wright'S Stain | IAF | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2025 | K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | POV | Substantially Equivalent | Bonraybio Co., Ltd. | accessdata.fda.gov |
| May 9, 2025 | K242388 | LensHooke X12 PRO Semen Analysis System | POV | Substantially Equivalent | Bonraybio Co., Ltd. | accessdata.fda.gov |
| October 31, 2022 | K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device | MQK | Substantially Equivalent | Bonraybio Co., Ltd. | accessdata.fda.gov |
| October 28, 2020 | K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | POV | Substantially Equivalent | Bonraybio Co., Ltd. | accessdata.fda.gov |
| November 16, 2018 | K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | POV | Substantially Equivalent | Bonraybio Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen, Non-Sterile
- All makers of Trypsin
- All makers of Labware, Assisted Reproduction
- All makers of Semen Analysis Device
- All makers of Counter, Differential Cell
- All makers of Stains, Hematology
Updated May 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.