Unified Business No.

54150856

Industry

Tobacco Manufacturing (1,186)

Listing

Listed (TPEx) (890) 6499

Founded

2012-12-22

Paid-in capital

NT$ 969,448,930

Phone

02-28816686

Website

https://www.medeonbiodesign.com/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Foreign-owned · United States · CENTER LABORATORIES INC.、Medeon,Inc. (USA)

North American market

FDA 510(k) clearance

Representative tenure

In office since 2025-08 (1 yrs); last handover 2025-08

Growth & profitability

Revenue 2026-09 YoY +513.1%, year-to-date +75.0%
Gross margin 13.3%, operating margin -123%, net margin -124% (2026-Q2 YTD)

Compliance record

Labour Standards Act penalties: 1 case(s) in 5 years, latest 2023-06-30, fines NT$ 20,000 (Art. 38) — matched by company name

North American market evidence 7

• FDA 510(k) clearance K200902 2020-04-30
  ClickClean
• FDA 510(k) clearance K193652 2020-03-26
  AbClose - Port Site Closure Device
• FDA 510(k) clearance K192891 2019-11-07
  Laparoscope Lens Shield Device (LENS)
• FDA 510(k) clearance K170103 2017-02-16
  Laparoscope Lens Shield Device (LENS)
• FDA 510(k) clearance K160117 2016-09-09
  AbClose - Port Site Closure Device
• FDA 510(k) clearance K160172 2016-04-21
  Laparoscope Lens Shield Device
• FDA 510(k) clearance K151117 2015-08-20
  Laparoscope Lens Shield Device

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• Medeologix Corporation · New Taipei City < NT$20M estimated
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• ALTEK BIOTECHNOLOGY CORPORATION · Hsinchu City < NT$20M estimated
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