SUNDER BIOMEDICAL TECH. CO., LTD.

Unified Business No.

16549813

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

No. 16, Zhongzheng Rd., Baozhong Township, Yunlin County 63441, Taiwan (R.O.C.)↗
Yunlin County (2,133) · Baozhong Township (50)

Listing

Emerging stock (TPEx) (359) 4115

Organisation type

Company Limited by Shares

Founded

1998-07-16

Paid-in capital

NT$ 600,000,000

Representative

Hu Chih-kai

Phone

(05)6976985

Website

https://www.sunder.com.tw/zh-tw/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$0.5–1B

Ownership

Individually held

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2013 (13+ years)

Growth & profitability

Revenue 2026-09 YoY +14.3%, year-to-date +0.8%
Gross margin 16.9%, operating margin 1%, net margin 0.7% (2026-Q2 YTD)

Certifications 75

• Medical device license (188)Official registry Valid until 2014-01-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2014-11-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2014-11-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2014-12-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2015-04-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2015-05-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2011-03-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2015-01-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (188)Official registry Valid until 2014-05-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-12-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-12-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-12-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-12-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-11-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2010-08-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-08-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-08-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-12-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-11-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-10-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2014-04-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-04-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-11-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-01-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-10-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-06-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-07-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-07-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-10-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-06-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-07-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-01-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2020-05-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-10-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2019-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-06-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-07-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2012-01-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-06-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2015-04-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-10-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-07-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2019-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-03-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-03-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-04-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2019-04-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-06-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-10-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-04-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2019-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-06-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-07-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-05-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2019-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-12-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-06-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2017-05-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-04-16 · Taiwan Food and Drug Administration (TFDA)
• CE Marking (162)Self-reported
• FDA (53)Self-reported
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported

Processes & materials 3

• Injection Molding (497) · FormingSelf-reported
• Cleanroom production (392) · Assembly & inspectionSelf-reported
• Assembly (901) · Assembly & inspectionSelf-reported

Patents 4

• 2023 Field-of-view auxiliary sheath for endoscope
• 2022 Field-of-view auxiliary sheath for endoscope
• 2021 Closed-type sputum suction tube controller

North American market evidence 4

• FDA 510(k) clearance K024007 2003-07-14
  SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J
• FDA 510(k) clearance K014140 2002-11-18
  RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET
• FDA 510(k) clearance K003123 2001-05-04
  RENAX A.V. FISTULA NEEDLE SETS
• FDA medical device registration 9616419 2007-08-29 – 2025-09-26
  Needle, Fistula; Set, Tubing, Blood, With And Without Anti-Regurgitation Valve; Tonsillectome and more (7)

Recent changes 4

• 2026-07-16
  Certification expiryMedical device license (Class II) certificate expired on 2026-07-16
• 2025-12-15
  Certification expiryMedical device license (Class I) certificate expired on 2025-12-15
• 2025-10-16
  Certification expiryMedical device license (Class II) certificate expired on 2025-10-16
• 2025-10-14
  Certification expiryMedical device license (Class I) certificate expired on 2025-10-14

RSS feed · Recent changes at Taiwanese manufacturers →

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