OSSAWARE BIOTECH CO., LTD.

Unified Business No.

53129440

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

No. 51, Xinggong Rd., Shengang Township, Changhua County 50971, Taiwan (R.O.C.)↗
Changhua County (11,429) · Shengang Township (513)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Huang Meng-feng

Phone

04-7977428

Website

https://ossaware.com/index.html

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Group subsidiary / corporate-held · Te Yi Tou Tzu Co., Ltd.、Yu Tse Kuo Chi Tou Tzu Co., Ltd.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2013 (13+ years)

Certifications 14

• Medical device license (Class I) (1,430)Official registry Valid until 2030-01-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-04-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-04-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-04-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-07-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-02-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-03-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-03-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-02-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-09-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-11-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-08-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-03-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-03-11 · Taiwan Food and Drug Administration (TFDA)

Processes & materials 1

• Biotechnology (664) · Company nameSelf-reported

Patents 2

• 2021 Multi-stage expansion device
• 2020 Bone drilling cover fixing device

North American market evidence 2

• FDA 510(k) clearance K192310 2020-06-03
  Flap Fixator, Burr Hole Cover
• FDA medical device registration 3013340866 2020-07-13 – 2021-03-11
  Cover, Burr Hole; Accessory, Surgical Apparel

Government programs & awards 2

• SBIR (Small Business Innovation Research) program 2019 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration
• SBIR (Small Business Innovation Research) program 2015 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Recent changes 1

• 2026-04-27
  Certification expiryMedical device license (Class I) certificate expired on 2026-04-27

RSS feed · Recent changes at Taiwanese manufacturers →

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