Unified Business No.

28844184

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

4 F., No. 1492-2, Chunri Rd., Taoyuan Dist., Taoyuan City 330022, Taiwan (R.O.C.)↗
Taoyuan City (10,976) · Taoyuan Dist. (907)

Listing

Not publicly issued (84,625)

Organisation type

Company Limited by Shares

Representative

Chang Yi-yi

Phone

03-3554989

Website

https://www.bomei.com.tw/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

< NT$20M estimated

Ownership

Group subsidiary / corporate-held · KAIYI TECHNOLOGY CO., LTD.

North American market

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

Representative tenure

In office since at least 2013 (13+ years)

Compliance record

Labour Standards Act penalties: 1 case(s) in 5 years, latest 2021-11-02, fines NT$ 20,000 (Art. 22) — matched by company name

Certifications 10

• Medical device license (Class I) (1,430)Official registry Valid until 2016-08-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-08-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-05-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-02-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2015-01-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-02-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2024-10-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-02-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-03-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2014-10-05 · Taiwan Food and Drug Administration (TFDA)

Patents 1

• 2020 Extension plate for correction nail

North American market evidence 4

• FDA 510(k) clearance K202278 2021-01-08
  OBS Anchorage Screw, Biokey Anchorage Screw
• FDA 510(k) clearance K152297 2016-02-09
  OBS Anchorage Screw
• FDA medical device registration 3012396434 2016-02-15 – 2021-01-11
  Implant, Endosseous, Orthodontic; Accessories, Implant, Dental, Endosseous; Instruments, Dental Hand
• Health Canada medical device licence 143159

Government programs & awards 2

• SBIR (Small Business Innovation Research) program 2016 · 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

Similar companies 10

• DERMACARE BIOMED INC. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class III), Medical equipment wholesale
• TI-HO HEALTHCARE TECHNOLOGY CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class III), Medical equipment wholesale
• EMSTREAM CORPORATION · Keelung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class III), Medical equipment wholesale
• LEIN YIH MEDICAL CO. · New Taipei City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class III), Medical consumables retail
• J.O. CORPORATION · Kaohsiung City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class III), Medical equipment wholesale
• ZE FANG TECHNOLOGY CO., LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class III)
• T-PLUS IMPLANT TECH. CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class III)
• M.D.B.T. CO., LTD. · Tainan City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class III)
• HUANG LIANG BIOMEDICAL TECHNOLOGY CO., LTD. · Kaohsiung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class III)
• AMED CO., LTD. · New Taipei City Public company (unlisted) NT$0.5–1B
  Shared: Medical device license (Class I), Medical device license (Class III), Medical consumables retail

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