Unified Business No.

24471156

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

6F, NO.6, SEC.1, ZHONGXING RD., WUGU DIST., NEW TAIPEI CITY, TAIWAN↗
New Taipei City (16,829) · Wugu Dist. (1,032)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2009-10-13

Paid-in capital

NT$ 170,121,000

Representative

Yen Miao-chuan

Phone

02-89769538

Website

https://baui.com.tw/zh/home_ch/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M estimated

Ownership

Group subsidiary / corporate-held · Hsuan Chen Kuo Chi Tou Tzu Ku Wen Co., Ltd.、Lien Yi Fa Co., Ltd.

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2013 (13+ years)

Plants 2

• Plant · 6F-1, 9F-13, 6F, No. 8, Sec. 1, Zhongxing Rd., Wugu Dist., New Taipei City↗ In production
• Plant 3 · 6F-1 Zhi -3, 6F-5 Zhi -6, 6F, No. 6, Sec. 1, Zhongxing Rd., Wugu Dist., New Taipei City↗ In production

Certifications 60

• Medical device license (Class I) (1,430)Official registry Valid until 2023-10-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-10-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-01-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-02-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-11-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-08-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-08-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-02-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-03-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-08-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-11-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-05-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2019-11-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-05-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-04-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-01-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-02-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-08-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-09-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-12-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-01-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-07-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-10-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-01-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-02-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-12-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-04-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-08-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-12-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-09-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-25 · 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 2031-01-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-11-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-09-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-09-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-11-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-06-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-06-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-02-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-07-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-08-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-10-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-10-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-12-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-01-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-06-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-07-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-06-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-02-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-01-11 · Taiwan Food and Drug Administration (TFDA)
• FDA (53)Self-reported

Processes & materials 3

• Biotechnology (664) · Company nameSelf-reported
• Engineering plastics (204) · PolymerSelf-reported
• Testing & inspection (1,056) · Assembly & inspectionSelf-reported

Patents 4

• 2025 Expandable working sleeve
• 2023 Interspinous distraction fixation device and stabilization device thereof
• 2022 Interspinous distraction fixation device and stabilization device thereof

North American market evidence 6

• FDA 510(k) clearance K242899 2024-10-17
  NOVA Minimally Invasive System
• FDA 510(k) clearance K191353 2020-04-14
  COMET Lumbar Interbody Fusion Cage
• FDA 510(k) clearance K191494 2019-08-12
  Facilis™ Spinal System
• FDA 510(k) clearance K182416 2019-06-11
  NOVA Minimally Invasive System
• FDA 510(k) clearance K161231 2017-01-23
  Facilis™ Spinal System
• FDA medical device registration 3013514648 2017-02-13 – 2024-11-24
  Thoracolumbosacral Pedicle Screw System; Appliance, Fixation, Spinal Interlaminal; Orthopedic Manual Surgical Instrument and more (4)

Government programs & awards 1

• SBIR (Small Business Innovation Research) program 2016 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Similar companies 10

• CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. · New Taipei City NT$0.5–1B estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Other pharmaceuticals & medical supplies wholesale n.e.c.
• A-SPINE Asia Co., Ltd. · New Taipei City Emerging stock (TPEx) NT$100–500M
  Shared: Biotechnology, Engineering plastics, Medical device license (Class I), Medical device license (Class II)
• DRX BIO CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Biotechnology, Testing & inspection, Medical device license (Class I), Medical device license (Class II)
• JBone Biotechnology Co.,Ltd. · Taoyuan City < NT$20M estimated
  Shared: Biotechnology, Medical device license (Class I), Medical device license (Class II), Medical consumables retail
• SHANYOU BIOTECH MEDICAL DEVICE CO., LTD. · Taichung City < NT$20M estimated
  Shared: Biotechnology, Medical device license (Class I), Medical device license (Class II), Medical device license (Class III)
• YIDING CO., LTD. · Tainan City < NT$20M estimated
  Shared: Biotechnology, Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c.
• HUNG CHUN BIO-S CO., LTD. · Kaohsiung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III)
• FUDAKANG INDUSTRIAL CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Medical consumables retail
• OSSAWARE BIOTECH CO., LTD. · Changhua County < NT$20M estimated
  Shared: Biotechnology, Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c.
• KeraBiotech Co., Ltd. · Tainan City < NT$20M estimated
  Shared: Biotechnology, Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c.

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