GALEMED CORPORATION

Unified Business No.

22320442

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

No. 87, Ligong 2nd Rd., Chengxing Vil., Wujie Township, Yilan County 268015, Taiwan (R.O.C.)↗
Yilan County (1,016) · Wujie Township (243)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Kung Kuo-chuan

Phone

03-9908618

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$100–500M estimated

Ownership

Group subsidiary / corporate-held · Chung Jen Taiwan Holdings Co., Ltd.

North American market

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

Representative tenure

In office since 2019-04 (7 yrs); last handover 2019-04

Compliance record

FDA import refusal: 1 product(s), latest 2020-10-19
Environmental penalties: 1 case(s) in 5 years, latest 2026-09-07, fines NT$ 6,000 (industrial waste)
Occupational safety penalties: 1 case(s) in 5 years, latest 2025-12-08, fines NT$ 60,000 (Art. 155) — matched by company name

Certifications 101

• ISO 9001 (4,293)Official registry Valid until 2027-04-03 · TÜV Rheinland Taiwan Ltd.
• Medical device license (188)Official registry Valid until 1997-07-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 1996-02-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 1996-02-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 1996-02-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 1996-04-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 1996-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 1996-07-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 1995-11-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-07-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-01-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-04-02 · 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 2024-10-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-10-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-10-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-11-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-12-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-12-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-12-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-12-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-12-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-12-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-07-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-04-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-04-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-07-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-08-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-08-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-03-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-03-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-03-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-06-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-12-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-09-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-11-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-09-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-08-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-10-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-10-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-08-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-06-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-05-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-05-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-05-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-05-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-05-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-05-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-05-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-06-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-07-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-07-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-02-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-02-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2011-03-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-12-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-09-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-11-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-06-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-04-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-07-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-04-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-10-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-10-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-12-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-12-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-12-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-05-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-01-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2018-10-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2019-04-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-03-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-05-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-09-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-07-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-07-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-06-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-08-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-08-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-08-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-09-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-06-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-07-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-02-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-12-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-03-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-12-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-02-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-01-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-02-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-03-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2018-04-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2024-11-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-12-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2015-12-10 · Taiwan Food and Drug Administration (TFDA)

Patents 3

• 2022 Atomizer with sensing structure
• 2022 Quick-release atomizer
• 2020 Fixing module for respirator

North American market evidence 5

• FDA 510(k) clearance K022124 2003-04-03
  GALEMED PEAK FLOW METER, MODELS 3751/3752
• FDA medical device registration 3011659673 2011-02-09 – 2023-05-13
  Clip, Nose; Exerciser, Non-Measuring For Stroke Rehabilitation; Exerciser, Non-Measuring
• FDA medical device registration 8043316 2002-07-26 – 2023-05-13
  Ventilator, Emergency, Manual (Resuscitator); Ventilator, Non-Continuous (Respirator); Attachment, Breathing, Positive End Expiratory Pressure and more (33)
• FDA import refusal 3003319165 2020-10-07 – 2020-10-19
  VENTILATOR, CONTINUOUS (RESPIRATOR)
• Health Canada medical device licence 113667

Recent changes 12

• 2027-01-18
  Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2027-01-18
• 2026-12-28
  Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-12-28
• 2026-10-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
• 2026-09-07
  PenaltiesEnvironmental penalties: latest case 2026-09-07; 1 case(s) in 5 years, fines NT$ 6,000
• 2026-07-07
  Certification expiryMedical device license (Class I) certificate expired on 2026-07-07
• 2026-07-07
  Certification expiryMedical device license (Class II) certificate expired on 2026-07-07
• 2026-06-14
  Certification expiryMedical device license (Class I) certificate expired on 2026-06-14
• 2026-05-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-05-31
• 2026-04-26
  Certification expiryMedical device license (Class I) certificate expired on 2026-04-26
• 2026-04-18
  Certification expiryMedical device license (Class I) certificate expired on 2026-04-18
• 2025-12-08
  PenaltiesOccupational safety penalties: latest case 2025-12-08; 1 case(s) in 5 years, fines NT$ 60,000
• 2025-10-30
  Certification expiryMedical device license (Class I) certificate expired on 2025-10-30

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 10

• 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.
• 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.
• 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.
• 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.
• YI LIN ENTERPRISE CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• TENNYSON MEDICAL INSTRUMENT DEVELOPING CO. · 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.
• SHINING WORLD HEALTH CARE CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• PERFECT MEDICAL INDUSTRY CO., LTD. · Changhua County Emerging stock (TPEx) NT$0.5–1B
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• CONPLUS INTERNATIONAL CO., LTD. · New Taipei City 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.
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