Unified Business No.

53853674

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

No. 77, Keji 1st Rd., Guishan Dist., Taoyuan City 333411, Taiwan (R.O.C.)↗
Taoyuan City (10,976) · Guishan Dist. (1,601)

Listing

Emerging stock (TPEx) (359) 7726

Organisation type

Company Limited by Shares

Founded

2012-05-23

Paid-in capital

NT$ 203,040,000

Representative

Cheng Wei-hsun

Phone

03-3287882

Website

https://carilexmedical.com/news/detail/13

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$100–500M

Ownership

Group subsidiary / corporate-held · Yung Chao Chuang Yeh Tou Tzu Co., Ltd.

North American market

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

Representative tenure

In office since 2021-02 (5 yrs); last handover 2021-02

Growth & profitability

Revenue 2026-09 YoY +15.8%, year-to-date +33.9%
Gross margin 44.7%, operating margin 1.5%, net margin 3.1% (2026-Q2 YTD)

Certifications 14

• Medical device license (Class I) (1,430)Official registry Valid until 2025-06-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-05-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-05-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-08-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-06-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-08-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-12-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-04-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-05-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-05-26 · Taiwan Food and Drug Administration (TFDA)
• CE Marking (162)Self-reported
• FDA (53)Self-reported
• ISO 13485 (310)Self-reported

North American market evidence 6

• FDA 510(k) clearance K231646 2024-04-17
  Carilex VT¿200-i NX
• FDA 510(k) clearance K173407 2018-08-09
  VT - 100, VT - 200
• FDA 510(k) clearance K172725 2018-06-08
  VT Dressing Kits
• FDA 510(k) clearance K161410 2016-10-13
  VT·One, VT·One 60days
• FDA medical device registration 9710603 2001-10-11 – 2026-07-23
  Negative Pressure Wound Therapy Powered Suction Pump; Dressing, Wound, Occlusive; Device, Patient Transfer, Powered and more (12)
• Health Canada medical device licence 187420

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, ISO 13485
• ROLENCE ENTERPRISE INC. · Taoyuan City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, ISO 13485
• IXENSOR CO., LTD. · Taipei City Emerging stock (TPEx) NT$20–100M
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, FDA
• GOLDEN SMART HOME TECHNOLOGY CORP. · Hsinchu City NT$100–500M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), FDA, ISO 13485
• 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
• BIOLIFE MEDICAL DEVICE INC. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c., General merchandise wholesale
• MEDIC TRADE CO., LTD. · Taoyuan City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• LAGIS ENTERPRISE CO., LTD. · Taichung City Listed (TPEx) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• YI LIEN MEDICAL CO., LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• JI SHENG MEDICAL COMPANY LIMITED · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.

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