Unified Business No.

24754176

Industry

Fabricated Metal Products (25,390)

Main products

Cutlery, hand tools & moulds (5,159)

Location

RM. B, 10F., NO.319, SEC. 2, DUNHUA S. RD., DA-AN DIST., TAIPEI CITY 106, TAIWAN, R.O.C.↗
New Taipei City (16,829) · Zhonghe Dist. (1,918)

Listing

Listed (TWSE) (1,087) 6934

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2014-10-06

Paid-in capital

NT$ 361,303,040

Representative

Cheng Chieh-sheng

Phone

02-27326596

Website

https://www.hcmed-inno.com/tw

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M

Ownership

Foreign-owned · United States · VIVOPANDAFUND,L.P. (USA)、An Juei Kuan Li Ku Wen Co., Ltd.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since 2014-10 (12 yrs)

Growth & profitability

Revenue 2026-09 YoY +822.9%, year-to-date +207.9%
Gross margin -165.9%, operating margin -493%, net margin -481.6% (2026-Q2 YTD)

Plants 3

• Plant · No. 1722F, No. 1743F, No. 1763F, 2F, No. 166, Jiankang Rd., Zhonghe Dist., New Taipei City↗ In production
• (zhong Hesan Chang) · No. 1583F, No. 1603F, 3F, No. 156, Jiankang Rd., Zhonghe Dist., New Taipei City↗ In production
• Zhonghe Plant 2 · 2F, No. 170, Jiankang Rd., Zhonghe Dist., New Taipei City↗ In production

Certifications 12

• Medical device license (Class I) (1,430)Official registry Valid until 2027-09-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-09-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-07-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-08-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-05-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-06-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-07-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-04-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-05-06 · Taiwan Food and Drug Administration (TFDA)
• FDA (53)Self-reported
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported

Processes & materials 1

• Assembly (901) · Assembly & inspectionSelf-reported

Patents 35

• 2025 Drug delivery device
• 2025 Atomization module
• 2025 Atomization device and atomization time prediction method therefor

North American market evidence 3

• FDA 510(k) clearance K250583 2025-06-20
  AdheResp Smart Breath-actuated Mesh Nebulizer
• FDA 510(k) clearance K202171 2021-07-01
  Pulmogine Vibrating Mesh Nebulizer
• FDA medical device registration 3016750005 2021-10-19 – 2025-12-23
  Nebulizer (Direct Patient Interface); Mask, Oxygen; Mouthpiece, Breathing

Government programs & awards 1

• SBIR (Small Business Innovation Research) program 2015 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Similar companies 10

• 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.
• HMD BIOMEDICAL INC. · Hsinchu County Public company (unlisted) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), FDA, GMP
• 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.
• HARITEX CORPORATION · Changhua County NT$20–100M estimated
  Shared: FDA, ISO 13485
• GOLDEN SMART HOME TECHNOLOGY CORP. · Hsinchu City NT$100–500M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), FDA, GMP
• SUNDER BIOMEDICAL TECH. CO., LTD. · Yunlin County Emerging stock (TPEx) NT$0.5–1B
  Shared: Assembly, Medical device license (Class I), Medical device license (Class II), FDA
• NAVIFUS CORPORATION · Taipei City Listed (TPEx) NT$20–100M
  Shared: Assembly, Medical device license (Class II), FDA, ISO 13485
• EZ MEDICA CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• PLEXBIO CO., LTD. · Taipei City Emerging stock (TPEx) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), FDA, GMP
• MEDIMAGING INTEGRATED SOLUTION, INC. · Hsinchu City Listed (TWSE) NT$0.5–1B
  Shared: Assembly, Medical device license (Class I), Medical device license (Class II), GMP

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