FORTUNE MEDICAL INSTRUMENT CORP.

Unified Business No.

22007273

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

6F., NO. 29, SEC. 2, JHONGJHENG E. RD., DANSHUEI DIST., NEW TAIPEI CITY 25173, TAIWAN↗
Taoyuan City (10,976) · Zhongli Dist. (1,194)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Wang Lien-kung

Phone

02-2624-2233

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$100–500M estimated

Ownership

Family-run (inferred)

North American market

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

Representative tenure

In office since at least 2014 (12+ years)

Compliance record

Occupational safety penalties: 1 case(s) in 5 years, latest 2025-09-26, fines NT$ 100,000 (Art. 57) — matched by company name

Certifications 38

• Medical device license (Class I) (1,430)Official registry Valid until 2031-04-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-04-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-07-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-01-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-08-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-03-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-05-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-08-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-07-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-07-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-09-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2010-10-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2011-01-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-01-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-04-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-01-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2011-12-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-01-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-02-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-09-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-08-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-09-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2020-03-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-08-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-09-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-09-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-01-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-05-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-06-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-05-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-12-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2014-04-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2019-11-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-07-07 · Taiwan Food and Drug Administration (TFDA)

Processes & materials 1

• Medical devices (32) · Company nameSelf-reported

Patents 4

• 2026 Negative pressure wound therapy system for assisting management of wound dressing usage status
• 2026 Negative pressure wound therapy system with dual-chamber manual suction system and pump body thereof
• 2024 Surgical instrument delivery tray

North American market evidence 6

• FDA 510(k) clearance K022112 2003-04-03
  FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
• FDA 510(k) clearance K021193 2003-02-12
  FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
• FDA 510(k) clearance K021142 2002-10-01
  ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
• FDA 510(k) clearance K014002 2002-03-04
  ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
• FDA medical device registration 8022978 1988-11-17 – 2026-02-23
  Tubes, Gastrointestinal (And Accessories); Catheter, Retention Type, Balloon; Gastrointestinal Tubes With Enteral Specific Connectors and more (27)
• Health Canada medical device licence 119783

Recent changes 3

• 2027-01-27
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2027-01-27
• 2027-01-26
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2027-01-26
• 2026-12-27
  Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-12-27

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 10

• Ace Medical Technology Co., Ltd. · Taoyuan City < NT$20M estimated
  Shared: Medical devices, Medical device license (Class I), Medical device license (Class II)
• Yang Cheng Medical Co., Ltd. · Taichung City < NT$20M estimated
  Shared: Medical devices, Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• LI Medical Corporation LTD. · New Taipei City < NT$20M estimated
  Shared: Medical devices, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• UNIK SURGICAL SUTURES MFG. CO. · New Taipei City NT$100–500M estimated
  Shared: Medical devices, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• SEN JEWEL TECHNOLOGY CO., LTD. · Taoyuan City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies retail n.e.c., Other medical devices & supplies manufacturing n.e.c.
• MEDICOM ASIA-PACIFIC HOLDINGS LIMITED TAIWAN BRANCH (HONG KONG) · Yilan County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies retail n.e.c., Other medical devices & supplies manufacturing n.e.c.
• EIKON HEALTHCARE DEVICE CORP. · New Taipei City NT$20–100M estimated
  Shared: Medical devices, Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• TAIWAN BIOMATERIAL COMPANY LIMITED · Hsinchu County Listed (TPEx) NT$100–500M
  Shared: Medical devices, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• CHANG HONG MEDICAL TECHNOLOGY INC. · Changhua County < NT$20M estimated
  Shared: Medical devices, Medical device license (Class I), Medical device license (Class II)
• LUCENS TECHNOLOGY INC. · Taoyuan City < NT$20M estimated
  Shared: Medical devices, Medical device license (Class II), Other pharmaceuticals & medical supplies retail n.e.c.

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