Browse by industry › Other Manufacturing

BIONIME CORPORATION

華廣生技股份有限公司

This is my company

Leave your email for change alerts (optional)

My watchlist →

2003Founded

NT$773MPaid-in capital

2Plants

84Certifications

68Patents

NT$1–5BRevenue band

Unified Business No.: 80310225
Industry: Other Manufacturing (2,432)
Main products: Medical devices & supplies (878)
Location: NO.100, SEC. 2, DAQING ST., SOUTH DIST.,TAICHUNG CITY 40242, TAIWAN (R.O.C.)
Taichung City (17,121) · South Dist. (341)
Listing: Listed (TWSE) (1,087) 4737
Registration status: Approved / Active
Organisation type: Company Limited by Shares
Founded: 2003-04-14
Paid-in capital: NT$ 773,280,530
Representative: Huang Chun-mu
Phone: 04-23692388
Website: http://www.bionime.com
Exporter: Yes — registered with the Trade Administration
Annual revenue band: NT$1–5B
Ownership: Mainland-China-owned · Mainland China · HUA ENG WIRE & CABLE CO., LTD.、Hua Jung Wire & Cable Co., Ltd.
North American market: FCC equipment authorization FDA 510(k) clearance FDA medical device registration Health Canada medical device licence
Representative tenure: In office since at least 2013 (13+ years)
Growth & profitability: Revenue 2026-09 YoY +20.9%, year-to-date -7.4%
Gross margin 33.8%, operating margin -16.9%, net margin -15.9% (2026-Q2 YTD)
Compliance record: FDA import refusal: 1 product(s), latest 2020-02-11
Environmental penalties: 1 case(s) in 5 years, latest 2022-04-07, fines NT$ 60,000 (industrial waste)
Occupational safety penalties: 1 case(s) in 5 years, latest 2025-01-02 (Art. 6) — matched by company name

Plants 2

Daqing Plant · No. 100, Sec. 2, Daqing St., South Dist., Taichung City In production
Dawei Plant · No. 34, Dawei Rd., Dali Dist., Taichung City In production

Certifications 84

ISO/IEC 27001 (112)Official registry · Huan'ao International Certification Co., Ltd.
Medical device license (Class I) (1,430)Official registry Valid until 2027-09-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-09-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-05-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-04-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-12-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-05-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2016-03-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2016-03-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2016-03-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2016-03-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2016-03-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-03-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-12-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2025-04-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2023-05-31 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-12-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-06-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2031-01-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-07-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-04-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-09-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-03-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2022-01-04 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-08-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-05-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2026-10-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2026-10-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2027-03-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2016-10-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2011-01-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2013-10-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2010-09-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2015-11-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2011-03-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-11-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-12-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-02-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-11-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2019-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-11-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-10-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-10-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-06-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-06-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-11-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-04-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-05-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-09-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-07-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-10-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-06-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-04-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-05-04 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-05-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-10-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2020-08-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-09-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-10-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-07-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-04-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2025-04-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2020-04-29 · 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 2020-12-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-03-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-04-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-05-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-11-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-05-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2017-01-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-07-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-07-17 · 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 2024-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-11-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-07-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-04-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-08-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-05-10 · Taiwan Food and Drug Administration (TFDA)

Processes & materials 1

Biotechnology (664) · Company nameSelf-reported

Patents 68

2026 Accessory kit for physiological parameter monitoring device
2026 Physiological signal sensing device and activation method thereof
2026 Transdermal glucose monitoring system

North American market evidence 12

FCC equipment authorization ADU
FDA 510(k) clearance K240637 2024-11-04
RIGHTEST Blood Glucose Monitoring System Max Tel
FDA 510(k) clearance K231192 2024-01-19
RIGHTEST Blood Glucose Monitoring System Max Tel
FDA 510(k) clearance K221062 2022-09-26
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
FDA 510(k) clearance K190564 2019-06-02
Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB
FDA 510(k) clearance K173638 2018-08-17
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus
FDA 510(k) clearance K173139 2018-06-19
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
FDA 510(k) clearance K170143 2017-07-06
GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,
FDA 510(k) clearance K161790 2017-05-02
iGlucose Blood Glucose Monitoring System
FDA medical device registration 3004183148 2007-10-29 – 2025-03-26
System, Test, Blood Glucose, Over The Counter; Glucose Oxidase, Glucose; Single (Specified) Analyte Controls (Assayed And Unassayed) and more (5)
FDA import refusal 3010543913 2020-02-11
SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Health Canada medical device licence 129497

Recent changes 2

2026-11-18
Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-11-18
2026-10-13
Certification expiryMedical device license (Class I) certificate expired on 2026-10-13

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 10

PULI BIOTECHNOLOGY CO., LTD. · Kaohsiung City < NT$20M estimated
Shared: Biotechnology, Medical device license (Class II), Medical consumables wholesale, In vitro diagnostic (IVD) reagent manufacturing
GENERAL LIFE BIOTECHNOLOGY CO.,LTD. · New Taipei City NT$100–500M estimated
Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., In vitro diagnostic (IVD) reagent manufacturing
FIRSTEP BIORESEARCH, INC. · Tainan City NT$100–500M estimated
Shared: Biotechnology, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
JBone Biotechnology Co.,Ltd. · Taoyuan City < NT$20M estimated
Shared: Biotechnology, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
DRX BIO CO., LTD. · New Taipei City < NT$20M estimated
Shared: Biotechnology, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
HAU-CHENG BIOTECH INC. · Hsinchu City < NT$20M estimated
Shared: Biotechnology, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
MAXIMA BIOTECH INC. · Taichung City < NT$20M estimated
Shared: Biotechnology, Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical consumables wholesale
HSI ERH SHENG ENTERPRISE CO., LTD. · Taichung City NT$20–100M estimated
Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical consumables wholesale
CODENT TECHNICAL INDUSTRY CO., LTD. · Kaohsiung City < NT$20M estimated
Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical consumables wholesale
ELINE MEDICAL CO., LTD. · Yilan County < NT$20M estimated
Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., Medical consumables wholesale

Open in advanced filters →