Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014053517

FEI Number

3014053517

Entity Name

BONRAYBIO CO., LTD.

City/State/Country

Taichung, TW

Establishment Address

4F., No. 118, Gongye 9th Rd., Dali Dist., Taichung 41280, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bonraybio Co., LTD. (Owner Number: 10055998)

Owner / Operator Contact Address

4F., No. 118, Gongye 9th Rd., Dali Dist., Taichung, TW-TXG 41280, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180343

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRF	Material, Quality Control, Semen Analysis	Hematology	Class 2	864.8625	2018-11-18
IAF	Wright'S Stain	Hematology	Class 1	864.1850	2020-10-27
GHO	Hemocytometer	Hematology	Class 1	864.6160	2023-03-28
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2025-06-16
IBG	Trypsin	Pathology	Class 1	864.4400	2020-11-02
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2022-11-16
KQC	Stains, Hematology	Hematology	Class 1	864.1850	2021-12-17
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2017-10-26
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2021-01-11
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2025-06-16
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2018-11-18
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2018-11-18

Official Correspondent

Brown Hsu

US Agent Details

Marissa Vilchez Email: m.vilchez@mdssar.com Phone: (312) 9751694

Related Public Records

Same Entity

Bonraybio Co., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K791007	Bioscientific	STAT DIFF STAIN	1979-08-03
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2012	EMD Chemicals Inc.	1	Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).

Similar Registrations

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3038206980	CHANGCHUN MERYDI BIO-TECH CO., LTD.	changchun Jilin, CN
3003646592	MEDICAL ELECTRONIC SYSTEMS LTD.	CAESAREA IND. PARK Haifa, IL
2025606	CalibreScientific US, Inc.	VANCOUVER, WA, US
3016090200	BONRAYBIO USA CORPORATION	Diamond Bar, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014053517. Last updated year: 2026. Please use registration number 3014053517 when referencing this establishment in official correspondence.