Unified Business No.

16570131

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

1 F., No. 10, Yanfa 2nd Rd., East Dist., Hsinchu City 30076, Taiwan (R.O.C.)↗
Hsinchu City (1,019) · East Dist. (401)

Listing

Listed (TPEx) (890) 1799

Organisation type

Company Limited by Shares

Founded

1998-08-10

Paid-in capital

NT$ 1,246,895,270

Representative

Lin Han-fei

Phone

(03)666-9596

Website

https://www.easywellbio.com/en/index.php

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$1–5B

Ownership

Group subsidiary / corporate-held · Chunghwa Shih Chi Tou Tzu Co., Ltd.、BayberryManagementLLC

North American market

FDA 510(k) clearance

Representative tenure

In office since 2018-11 (8 yrs); last handover 2018-11

Growth & profitability

Revenue 2026-09 YoY +80.6%, year-to-date +78.6%
Gross margin 47.8%, operating margin 4.1%, net margin 2.1% (2026-Q2 YTD)

Certifications 15

• Medical device license (188)Official registry Valid until 2011-04-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-09-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-01-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-03-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-03-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-09-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-09-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-09-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2018-10-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2022-06-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2019-08-18 · Taiwan Food and Drug Administration (TFDA)
• CE Marking (162)Self-reported
• FDA (53)Self-reported

North American market evidence 2

• FDA 510(k) clearance K163166 2017-08-11
  EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
• FDA 510(k) clearance K162509 2017-03-10
  Infrared Non-contact Thermometer, Model ACT8100

Similar companies 10

• 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
• BIOCARE CORPORATION · Taoyuan City NT$20–100M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other merchandise wholesale brokerage n.e.c.
• UNITED ORTHOPEDIC CORPORATION · Hsinchu City Listed (TPEx) ≥ NT$5B
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• NEW DEANTRONICS TAIWAN LTD. · Chiayi County < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• GALEMED CORPORATION · Yilan County NT$100–500M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• SUNDER BIOMEDICAL TECH. CO., LTD. · Yunlin County Emerging stock (TPEx) NT$0.5–1B
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), CE Marking
• Lien Sheng Yi Liao Wei Tsai Co., Ltd. · Changhua County < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• YU Kuang Industrial CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license, Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• BIOTECH ONE INC. · Hsinchu County < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• S. MES. CO., LTD. · Pingtung County NT$20–100M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II)

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