Unified Business No.

24316471

Industry

Tobacco Manufacturing (1,186)

Listing

Listed (TPEx) (890) 4188

Founded

2008-12-26

Paid-in capital

NT$ 633,329,000

Phone

02-27136227

Website

https://www.amcad.com.tw/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M

Ownership

Group subsidiary / corporate-held · PHYTOHEALTH CORPORATION、MAYWUFA COMPANY LTD.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since 2020-11 (6 yrs); last handover 2020-11 (same surname)

Growth & profitability

Revenue 2026-09 YoY -62.2%, year-to-date -16.9%
Gross margin 42.6%, operating margin -311.3%, net margin -271.1% (2026-Q2 YTD)

Certifications 7

• Medical device license (Class I) (1,430)Official registry Valid until 2024-03-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-01-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-11-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-02-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-01-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-12-26 · Taiwan Food and Drug Administration (TFDA)
• CE Marking (162)Self-reported

Patents 1

• 2025 Method for predicting risk of sleep apnea

North American market evidence 6

• FDA 510(k) clearance K203555 2021-09-08
  AmCAD-UT
• FDA 510(k) clearance K180867 2018-12-28
  AmCAD-UO
• FDA 510(k) clearance K180006 2018-08-31
  AmCAD-UT Detection 2.2
• FDA 510(k) clearance K162574 2017-05-30
  AmCAD-US
• FDA 510(k) clearance K170069 2017-04-26
  AmCAD-UV
• FDA medical device registration 3015218501 2019-01-31 – 2021-11-30
  System, Image Processing, Radiological; Monitor, Patient Position, Light-Beam; Automated Radiological Image Processing Software

Similar companies 10

• HEALTH & LIFE CO., LTD. Listed (TPEx) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• EVER FORTUNE.AI CO., LTD. Listed (TPEx) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• AMAGCARE TECHNOLOGIES INC. · Kaohsiung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• MERITS HEALTH PRODUCTS CO., LTD. · Taichung City NT$0.5–1B estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• RECO-DENT INTERNATIONAL CO., LTD. · 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.
• HEARTWAY MEDICAL PRODUCTS 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.
• ROLENCE ENTERPRISE INC. · Taoyuan City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, Other medical devices & supplies manufacturing n.e.c.
• EXCELSIOR BIOPHARMA INCORPORATION Listed (TPEx) NT$0.5–1B
  Shared: Medical device license (Class I), Medical device license (Class II)
• DADSUN CORPORATION 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.
• GIMER MEDICAL COMPANY LIMITED Public company (unlisted) < NT$20M
  Shared: Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.

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