LITE-MED INC.

Unified Business No.

86024065

Industry

Computers, Electronics & Optical Products (2,116)

Main products

Radiation & electro-medical equipment (120)

Location

9 F., No. 49, Dongxing Rd., Xinyi Dist., Taipei City 11070, Taiwan (R.O.C.)↗
New Taipei City (16,829) · Xindian Dist. (687)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

1991-04-03

Paid-in capital

NT$ 81,000,000

Representative

Wu Jung-chu

Phone

02-87681316

Website

https://lite-med.com

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M estimated

Ownership

Individually held

North American market

FDA 510(k) clearance

Representative tenure

In office since at least 2013 (13+ years)

Compliance record

Labour Standards Act penalties: 2 case(s) in 5 years, latest 2022-09-02, fines NT$ 40,000 (Art. 30; Art. 23) — matched by company name

Plants 2

• Plant · 8F, No. 45, Fuxing Rd., Xindian Dist., New Taipei City↗ In production
• Xindian Plant 2 · 4F, No. 190, Sec. 2, Zhongxing Rd., Xindian Dist., New Taipei City↗ In production

Certifications 27

• Medical device license (188)Official registry Valid until 2009-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2005-05-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2007-11-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2011-03-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-06-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-03-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-12-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-03-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-06-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-07-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-10-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-06-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-06-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2013-11-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2013-10-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-01-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2027-09-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2027-06-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2031-06-20 · Taiwan Food and Drug Administration (TFDA)
• ISO 13485 (310)Self-reported

Patents 3

• 2025 Shock wave therapy device combined with ultrasonic probe
• 2023 Shock wave therapy device for interstitial cystitis
• 2020 Glans cover structure of foreskin cutter

North American market evidence 3

• FDA 510(k) clearance K213772 2023-01-19
  LM-9300 Plus Lithotripter
• FDA 510(k) clearance K142561 2015-03-20
  LM-9300 ELMA Lithotripter
• FDA 510(k) clearance K103217 2011-09-28
  LITE-MED LM-9200 ELMA

Government programs & awards 1

• SBIR (Small Business Innovation Research) program 2017 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Recent changes 1

• 2026-06-30
  Certification expiryMedical device license (Class I) certificate expired on 2026-06-30

RSS feed · Recent changes at Taiwanese manufacturers →

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