FDA Registration
Active
🇹🇼 Taiwan
BONRAYBIO CO., LTD.
Reg #: 3014053517
·
FEI: 3014053517
·
Expires 2026
Products
9
Proprietary Names
24
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- BONRAYBIO CO., LTD.
- Registration Number
- 3014053517
- FEI Number
- 3014053517
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4F., No. 118, Gongye 9th Rd., Dali Dist.
- City
- Taichung
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K242830
Owner / Operator
- Firm Name
- Bonraybio Co., LTD.
- Operator Number
- 10055998
- Address
- 4F., No. 118, Gongye 9th Rd., Dali Dist.
- City
- Taichung
- State
- TW-TXG
- Postal Code
- 41280
- Country
- TW
- Correspondent
- Brown Hsu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Quality Control, Semen Analysis | NRF | Class 2 | Hematology | No | 2018-11-18 |
| Wright'S Stain | IAF | Class 1 | Hematology | No | 2020-10-27 |
| Hemocytometer | GHO | Class 1 | Hematology | No | 2023-03-28 |
| Semen Analysis Device | POV | Class 2 | Hematology | No | 2025-06-16 |
| Trypsin | IBG | Class 1 | Pathology | No | 2020-11-02 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2022-11-16 |
| Stains, Hematology | KQC | Class 1 | Hematology | No | 2021-12-17 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2017-10-26 |
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2018-11-18 |
Proprietary Names
LensHooke X QC Beads (For Semen)
LensHooke X QC Reticle (For Semen)
LensHooke X QC Video (For Semen)
LensHooke X QC Slide (For Semen)
LensHooke Sperm DNA Fragmentation Test Kit (SCD Assay)
LensHooke Sperm DNA Fragmentation Rapid Test Kit (SCD Assay)
LensHooke Prestained Morphology Slide CR0
LensHooke Semen Test Slide CS3
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer; LensHooke CS1 Semen Test Cassette
LensHooke Cleaning Wipe CW0; LensHooke Cleaning Wipe CW1; LensHooke Cleaning Wipe Holder CWA
LensHooke Liquefaction Enzyme
LensHooke CA0 Sperm Separation Device
LensHooke CA1 Sperm Separation Device
LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)
C-KUP Liquefaction Test Cup
LensHooke X1 PRO Semen Quality Analyzer ; LensHooke X1 PRO SE Semen Quality Analyzer
LensHooke Semen Test Cassette CS0;LensHooke Semen Test Cassette CS1
LensHooke Cleaning Wipe CW0; LensHooke Cleaning Wipe CW1
LensHooke R10 Plus Sperm DNA fragmentation Rapid Test Kit (SCD assay)
LensHooke R11 Plus Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)
LensHooke X12 PRO Semen Analysis System; LensHooke CS3 10?m Semen Test Slide
LensHooke X1 Semen Quality Analyzer
LensHooke Semen Test Cassette
LensHooke X1 PRO Semen Quality Analyzer
Establishment Types
Manufacture Medical Device