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TYSON BIORESEARCH INC.

台欣生物科技研發股份有限公司

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1Plants

48Certifications

1Patents

NT$20–100MRevenue band (est.)

Unified Business No.: 70453835
Industry: Other Manufacturing (2,432)
Main products: Medical devices & supplies (878)
Location: 5 F., No. 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 350401, Taiwan (R.O.C.)
Miaoli County (1,771) · Zhunan Township (480)
Listing: Not publicly issued (84,625)
Organisation type: Company Limited by Shares
Representative: Wang Hsiu-chen
Phone: 03-7585988
Exporter: Yes — registered with the Trade Administration
Annual revenue band: NT$20–100M estimated
Ownership: Group subsidiary / corporate-held · Tai Hsin Holdings Co., Ltd.
North American market: FCC equipment authorization FDA 510(k) clearance FDA medical device registration
Representative tenure: In office since at least 2014 (12+ years)
Compliance record: Environmental penalties: 1 case(s) in 5 years, latest 2022-01-03, fines NT$ 60,000 (toxic chemicals)

Certifications 48

Medical device license (Class I) (1,430)Official registry Valid until 2028-10-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-12-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-08-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-08-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-09-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2015-11-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-07-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-11-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-09-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-09-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-05-31 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-09-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2010-10-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2011-03-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2022-08-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-07-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-07-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2016-09-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2017-06-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2010-10-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2014-10-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2018-12-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2016-09-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2014-01-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2022-09-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2022-10-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-08-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-01-31 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2020-11-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2012-08-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2017-08-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-11-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2015-12-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-06-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-08-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-09-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2013-06-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2012-01-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-06-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2014-04-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-10-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-10-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class III) (94)Official registry Valid until 2012-08-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class III) (94)Official registry Valid until 2012-09-04 · Taiwan Food and Drug Administration (TFDA)

Patents 1

2020 Blood glucose test strip and method of use

North American market evidence 14

FCC equipment authorization 2AJZ6 2016-10-12
FDA 510(k) clearance K182046 2018-11-30
Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System
FDA 510(k) clearance K182047 2018-11-29
Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System
FDA 510(k) clearance K170079 2017-10-06
Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System
FDA 510(k) clearance K123087 2013-06-18
TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k) clearance K112916 2012-08-21
TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM
FDA 510(k) clearance K101543 2011-08-30
TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
FDA 510(k) clearance K090629 2009-06-04
EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
FDA 510(k) clearance K081726 2008-08-26
TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
FDA 510(k) clearance K072854 2008-06-30
DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k) clearance K073492 2008-04-08
DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k) clearance K072441 2008-03-25
EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k) clearance K062829 2006-10-10
DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
FDA medical device registration 3003132490 2008-05-08 – 2019-01-02
System, Test, Blood Glucose, Over The Counter; Glucose Oxidase, Glucose; Single (Specified) Analyte Controls (Assayed And Unassayed)

Recent changes 1

2026-12-23
Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-12-23

RSS feed · Recent changes at Taiwanese manufacturers →

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