BONRAYBIO CO., LTD.
邦睿生技股份有限公司
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2016Founded
NT$248MPaid-in capital
1Plants
14Certifications
11Patents
NT$100–500MRevenue band
- Unified Business No.
- 42686138
- Industry
- Other Manufacturing (2,432)
- Main products
- Medical devices & supplies (878)
- Location
- 4F., NO.118, GONGYE 9TH RD., DALI DIST.,TAICHUNG CITY 41280, TAIWAN (R.O.C.)
Taichung City (17,121) · Dali Dist. (1,865) - Listing
- Listed (TWSE) (1,087) 6955
- Organisation type
- Company Limited by Shares
- Founded
- 2016-01-12
- Paid-in capital
- NT$ 248,007,850
- Representative
- Hsu Chen-teng
- Phone
- (04)2491-2385
- Website
- https://www.bonraybio.com/tw
- Exporter
- Yes — registered with the Trade Administration
- Annual revenue band
- NT$100–500M
- North American market
- FCC equipment authorization FDA 510(k) clearance FDA medical device registration Health Canada medical device licence
- Representative tenure
- In office since 2016-01 (10 yrs)
- Growth & profitability
- Revenue 2026-09 YoY +14.5%, year-to-date +17.7%
Gross margin 77.5%, operating margin 31.7%, net margin 29.6% (2026-Q2 YTD) - Compliance record
- FDA import refusal: 1 product(s), latest 2019-10-07
Certifications 14
- Medical device license (Class I) (1,430)Official registry Valid until 2025-12-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-08-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2023-03-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2030-05-04 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2028-04-25 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2028-11-16 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2025-03-20 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2023-01-17 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-12-11 · Taiwan Food and Drug Administration (TFDA)
Processes & materials 1
- Biotechnology (664) · Company nameSelf-reported
Patents 11
- 2025 Pre-staining detection device
- 2024 Biological sample detection device
- 2024 Sperm sorting device and method
North American market evidence 9
- FCC equipment authorization 2ANLS 2017-09-03
- FDA 510(k) clearance K242830 2025-05-30
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer - FDA 510(k) clearance K242388 2025-05-09
LensHooke X12 PRO Semen Analysis System - FDA 510(k) clearance K221810 2022-10-31
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device - FDA 510(k) clearance K202089 2020-10-28
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer - FDA 510(k) clearance K180343 2018-11-16
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer - FDA medical device registration 3014053517 2017-10-26 – 2025-06-16
Semen Analysis Device; Labware, Assisted Reproduction; Container, Specimen, Non-Sterile and more (9) - FDA import refusal 3014053517 2019-10-07
SEMEN ANALYSIS DEVICE - Health Canada medical device licence 192243
Public registers of the US FDA, the FCC and Health Canada, matched on the registered English name. An FDA import refusal is a negative record, but also shows goods actually shipped to the US. The FCC dataset ends in 2021.
Recent changes 3
- Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
- Certification expiryMedical device license (Class I) certificate expired on 2026-08-12
- Certification expiryMedical device license (Class I) certificate expired on 2025-12-11
RSS feed · Recent changes at Taiwanese manufacturers →
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