UNIMAX MEDICAL SYSTEMS INC.

Unified Business No.

70552259

Industry

Other Manufacturing (2,432)

Main products

Plastic products (7,635)

Location

8 F.-2, No. 127, Ln. 235, Baoqiao Rd., Xindian Dist., New Taipei City 231028, Taiwan (R.O.C.)↗
Yilan County (1,016) · Wujie Township (243)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Limited Company

Founded

2000-04-25

Paid-in capital

NT$ 136,000,000

Representative

Hsieh Chin-chen

Phone

02-89191698

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M estimated

Ownership

Individually held

North American market

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

Representative tenure

In office since at least 2015 (11+ years)

Compliance record

Labour Standards Act penalties: 1 case(s) in 5 years, latest 2024-09-13, fines NT$ 100,000 (Art. 24) — matched by company name

Plants 2

• Yilan Plant · No. 37, Sec. 2, Ligong 1st Rd., Wujie Township, Yilan County↗ In production
• Xindian Plant · 8F-2, No. 127, Ln. 235, Baoqiao Rd., Xindian Dist., New Taipei City↗ In production

Certifications 57

• Medical device license (188)Official registry Valid until 2011-02-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-02-17 · 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 2031-12-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-04-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-10-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-06-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-08-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-08-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-11-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-05-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-05-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-06-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-06-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-09-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-11-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-02-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-05-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-03-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-05-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-05-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-11-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-04-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-06-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-04-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-10-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2012-10-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-09-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-11-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2016-04-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2011-03-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2011-03-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2013-12-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-12-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-07-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-09-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-02-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-06-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-07-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-12-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-07-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-05-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-06-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-11-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-04-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-09-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-02-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-04-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-06-03 · Taiwan Food and Drug Administration (TFDA)

Patents 1

• 2021 Sealing module structure for puncture cannula

North American market evidence 10

• FDA 510(k) clearance K211577 2021-11-05
  SoftFix Balloon Trocar
• FDA 510(k) clearance K103508 2011-12-20
  UNMIAX LAPAROSCOPIC INSTRUMENT
• FDA 510(k) clearance K112358 2011-10-17
  UNIMAX TROCAR SYSTEM
• FDA 510(k) clearance K111622 2011-09-09
  UNIMAX ANTI-FOG SOLUTION
• FDA 510(k) clearance K111441 2011-08-19
  UNIMAX VERESS NEEDLE
• FDA 510(k) clearance K103509 2011-05-19
  UNIMAX SUCTION IRRIGATION SET
• FDA 510(k) clearance K103510 2011-05-06
  UNIMAX SPECIMEN RETRIEVAL SYSTEM
• FDA medical device registration 3007791595 2009-07-13 – 2026-08-06
  Laparoscope, General & Plastic Surgery; Ring (Wound Protector), Drape Retention, Internal; Catheter And Tip, Suction and more (13)
• FDA medical device registration 3015497424 2009-07-13 – 2026-08-06
  Laparoscope, General & Plastic Surgery; Insufflator, Laparoscopic; Pneumoperitoneum Needle and more (13)
• Health Canada medical device licence 133498

Recent changes 3

• 2027-02-02
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2027-02-02
• 2026-11-17
  Certification expiry · UpcomingMedical device license (Class I) certificate expires on 2026-11-17
• 2026-09-30
  Certification expiryMedical device license (Class II) certificate expired on 2026-09-30

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 10

• GALEMED CORPORATION · Yilan County NT$100–500M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II)
• NEW DEANTRONICS TAIWAN LTD. · Chiayi County < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II)
• UNITED ORTHOPEDIC CORPORATION · Hsinchu City Listed (TPEx) ≥ NT$5B
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II)
• 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)
• SYMPHON MEDICAL TECHNOLOGY CO., LTD. · New Taipei City NT$100–500M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II)
• BIOTECH ONE INC. · Hsinchu County < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II)
• YONG LI TECHNIQUE CO., LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II)
• 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)
• TENNYSON MEDICAL INSTRUMENT DEVELOPING CO. · Changhua County < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II)
• 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)

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