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BIOPTIK TECHNOLOGY, INC.

聿新生物科技股份有限公司

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1999Founded

NT$598MPaid-in capital

5Plants

95Certifications

3Patents

NT$0.5–1BRevenue band

Unified Business No.: 16930971
Industry: Other Manufacturing (2,432)
Main products: Medical devices & supplies (878)
Location: No. 188, Jhonghua South Road, Gongguan Village, Jhunan Township, Miaoli County, 35057 Taiwan
Hsinchu City (1,019) · East Dist. (401)
Listing: Listed (TPEx) (890) 4161
Registration status: Approved / Active
Organisation type: Company Limited by Shares
Founded: 1999-06-01
Paid-in capital: NT$ 598,082,040
Representative: Yang Chin-chang
Phone: 037-626699
Website: https://www.bioptik.com.tw/tw/
Exporter: Yes — registered with the Trade Administration
Annual revenue band: NT$0.5–1B
Ownership: Individually held
North American market: FDA medical device registration
Representative tenure: In office since at least 2013 (13+ years)
Growth & profitability: Revenue 2026-09 YoY -41.1%, year-to-date +9.1%
Gross margin 28%, operating margin 7.8%, net margin 11.9% (2026-Q2 YTD)

Plants 5

Tainan Plant 1 · 4F, 3F, No. 1, Guanghua St., Xinshi, Tainan City In production
Hsinchu Kexue Fengongsi Fengong Plant 1 · 1F, No. 18, Gongye E. 4th Rd. (Hsinchu Science Park), East Dist., Hsinchu City In production
Hsinchu Kexue Fengongsi Fengong Plant 3 · 1F, No. 20, Gongye E. 4th Rd. (Hsinchu Science Park), East Dist., Hsinchu City In production
Hsinchu Kexue Fengongsi Fengong Plant 4 · 2F, No. 18, Gongye E. 4th Rd. (Hsinchu Science Park), East Dist., Hsinchu City In production
Plant · No. 188, Chunghwa S. Rd., Zhunan Township, Miaoli County In production

Certifications 95

Medical device license (Class I) (1,430)Official registry Valid until 2024-01-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-10-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-02-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-09-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-06-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-07-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-08-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-09-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-09-04 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-09-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-12-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-01-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-04-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-04-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2013-06-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-04-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-12-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-10-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-11-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-07-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2011-09-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2011-09-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-11-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-12-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2024-12-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-12-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-11-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-01-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-01-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-01-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-01-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2021-06-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-02-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-05-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-03-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-05-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2023-04-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2017-05-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-10-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-09-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2026-12-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-04-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2024-07-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-09-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2017-03-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2017-05-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2017-06-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2017-12-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-10-31 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2015-10-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2011-02-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-09-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-11-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-12-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-05-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-05-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2020-09-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-09-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-11-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-04-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-07-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-01-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-09-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2015-10-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-01-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-04-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-05-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-01-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-01-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-06-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-05-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-05-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-05-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-06-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-05-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-05-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-05-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-11-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2025-01-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-09-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2015-10-27 · Taiwan Food and Drug Administration (TFDA)
GMP (261)Self-reported
HACCP (229)Self-reported
ISO 13485 (310)Self-reported
ISO 22000 (760)Self-reported
ISO 9001 (4,293)Self-reported

Processes & materials 2

Copper alloy (324) · MetalSelf-reported
Precision machining (353) · MachiningSelf-reported

Patents 3

2023 Handheld plasma generator
2022 Resistive-type determination test strip structure
2019 Preparation system for astaxanthin compound composition

North American market evidence 1

FDA medical device registration 3005706626 2007-12-05
Multi-Analyte Controls, All Kinds (Assayed); System, Test, Blood Glucose, Over The Counter

Recent changes 1

2026-12-08
Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2026-12-08

RSS feed · Recent changes at Taiwanese manufacturers →

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