OK BIOTECH CO., LTD.

Unified Business No.

27453928

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

No. 91, Sec. 2, Gongdao 5th Rd., East Dist., Hsinchu City 300046, Taiwan (R.O.C.)↗
Hsinchu City (1,019) · East Dist. (401)

Listing

Listed (TWSE) (1,087) 4155

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2004-09-27

Paid-in capital

NT$ 1,446,841,640

Representative

Lai Chia-te

Phone

03-5160258

Website

https://www.okbiotech.com/zh-tw

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$1–5B

Ownership

Group subsidiary / corporate-held · Ho Chun Tou Tzu Co., Ltd.、Ting Fa Tou Tzu Co., Ltd.、Shang Shun Tou Tzu Co., Ltd.、Pei Hsi Co., Ltd.

North American market

FDA 510(k) clearance FDA medical device registration Health Canada medical device licence

Representative tenure

In office since at least 2013 (13+ years)

Growth & profitability

Revenue 2026-09 YoY +60.0%, year-to-date +13.9%
Gross margin 30.8%, operating margin 13.6%, net margin 13.7% (2026-Q2 YTD)

Plants 3

• Plant · 2-6F, No. 91, 91, Sec. 2, Gongdao 5th Rd., East Dist., Hsinchu City↗ In production
• Plant 1 · No. 83, 85, Sec. 2, Gongdao 5th Rd., East Dist., Hsinchu City↗ In production
• Plant 2 · 3F, No. 158, Ln. 99, Puding Rd., East Dist., Hsinchu City↗ In production

Certifications 86

• Medical device license (Class I) (1,430)Official registry Valid until 2026-08-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-03-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-09-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-01-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-06-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-03-16 · 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 2027-12-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-01-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-03-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-02-21 · 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 2016-08-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-11-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-12-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-05-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-02-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-02-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-02-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-06-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-11-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-11-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2018-03-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-26 · 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 2030-02-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-11-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-04-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-09-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-02-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-10-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-10-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2022-08-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-02-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-08-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-04-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2018-09-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-02-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-12-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-08-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-11-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-02-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-08-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-07-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-07-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-07-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-07-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-07-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-08-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-06-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-07-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-07-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2022-11-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-05-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-01-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-07-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-08-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-02-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-03-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-12-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-01-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2020-03-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-04-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-06-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-10-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-06-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-03-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-26 · 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 2031-07-02 · Taiwan Food and Drug Administration (TFDA)
• FDA (53)Self-reported
• ISO 13485 (310)Self-reported

Processes & materials 2

• Optoelectronics (337) · Company nameSelf-reported
• Testing & inspection (1,056) · Assembly & inspectionSelf-reported

Patents 3

• 2026 Separable seamless transmission hearing aid and wearable seamless transmission hearing aid
• 2020 Tour bus
• 2019 Separable hearing aid

North American market evidence 11

• FDA 510(k) clearance K213061 2022-10-07
  SuperCheck Pro Blood Glucose Monitoring System
• FDA 510(k) clearance K162430 2017-01-19
  UniStrip1 Generic Blood Glucose Test Strips
• FDA 510(k) clearance K160038 2016-07-29
  UniStrip1 Generic Blood Glucose Test Strips
• FDA 510(k) clearance K152599 2016-07-20
  PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System
• FDA 510(k) clearance K142785 2015-12-17
  PRODIGY iConnect Blood Glucose Monitoring System
• FDA 510(k) clearance K141914 2015-04-15
  PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
• FDA 510(k) clearance K132633 2014-08-14
  OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM
• FDA 510(k) clearance K090609 2010-02-04
  OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM
• FDA 510(k) clearance K063026 2007-02-09
  OK METER BLOOD GLUCOSE MONITORING SYSTEM
• FDA medical device registration 3005862821 2006-08-09 – 2025-06-25
  System, Test, Blood Glucose, Over The Counter; Glucose Oxidase, Glucose; Single (Specified) Analyte Controls (Assayed And Unassayed) and more (10)
• Health Canada medical device licence 147503

Recent changes 4

• 2027-01-19
  Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2027-01-19
• 2026-12-29
  Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-12-29
• 2026-08-24
  Certification expiryMedical device license (Class I) certificate expired on 2026-08-24
• 2026-06-24
  Certification expiryMedical device license (Class II) certificate expired on 2026-06-24

RSS feed · Recent changes at Taiwanese manufacturers →

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