Unified Business No.

53927676

Industry

Other Manufacturing (2,436)

Main products

Medical devices & supplies (878)

Location

6 F., No. 9, Aly. 2, Ln. 35, Jihu Rd., Neihu Dist., Taipei City 114066, Taiwan (R.O.C.)↗
Taipei City (812) · Neihu Dist. (356)

Listing

Emerging stock (TPEx) (359) 6734

Organisation type

Company Limited by Shares

Founded

2012-08-30

Paid-in capital

NT$ 406,231,640

Representative

Chen Yen-yu

Phone

87511335

Website

https://www.ixensor.com/ixensor_web/zh-hant/%e9%97%9c%e6%96%bc%e6%88%91%e5%80%91/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M

Ownership

Group subsidiary / corporate-held · Yuan Chan Kuan Li Ku Wen Co., Ltd.

North American market

FCC equipment authorization FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since 2022-08 (4 yrs); last handover 2022-08

Growth & profitability

Revenue 2026-09 YoY +310.0%, year-to-date +12.1%
Gross margin 36.1%, operating margin -226.5%, net margin -230.1% (2026-Q2 YTD)

Certifications 24

• Medical device license (Class I) (1,430)Official registry Valid until 2020-06-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-12-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-03-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-06-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-03-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-11-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-10-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-01-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-04-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-12-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-06-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-11-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-03-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-06-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-02-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-09-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-05-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-07-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-08-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-07-10 · Taiwan Food and Drug Administration (TFDA)
• CE Marking (162)Self-reported
• FDA (53)Self-reported
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported

Patents 3

• 2025 System and method for performing quantitative polymerase chain reaction
• 2024 System, method and non-transitory computer-readable medium for performing quantitative polymerase chain reaction
• 2021 Device and method for determining biological property using test strip meter

North American market evidence 5

• FCC equipment authorization 2APWS 2018-05-21
• FDA 510(k) clearance K192369 2019-10-29
  PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
• FDA 510(k) clearance K181915 2019-04-12
  PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
• FDA 510(k) clearance K163087 2017-11-02
  PixoTest Blood Glucose Monitoring System
• FDA medical device registration 3011061417 2014-12-18 – 2025-04-02
  Assay, Glycosylated Hemoglobin; Colorimetric Method, Triglycerides; Ventilatory Effort Recorder and more (8)

Similar companies 10

• HMD BIOMEDICAL INC. · Hsinchu County Public company (unlisted) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), FDA, GMP
• GOLDEN SMART HOME TECHNOLOGY CORP. · Hsinchu City NT$100–500M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), FDA, GMP
• ROLENCE ENTERPRISE INC. · Taoyuan City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP
• FREE BIONICS TAIWAN INC. · Hsinchu City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP
• CARILEX MEDICAL, INC. · Taoyuan City Emerging stock (TPEx) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, FDA
• PEGAVISION CORPORATION · Taoyuan City Listed (TWSE) ≥ NT$5B
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• CHIH CHI MEDICAL LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), ISO 13485, Other management consulting n.e.c.
• SUNDER BIOMEDICAL TECH. CO., LTD. · Yunlin County Emerging stock (TPEx) NT$0.5–1B
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, FDA
• FAIRY POLYMER INDUSTRY CO., LTD. · Tainan City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), ISO 13485, Medical equipment wholesale
• ACER MEDICAL INC. · New Taipei City Emerging stock (TPEx) NT$20–100M
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485

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