MAXIGEN BIOTECH INC.

Unified Business No.

16749811

Industry

Other Manufacturing (2,432)

Main products

Medical devices & supplies (878)

Location

No. 88, Keji 1st Rd., Guishan Dist., Taoyuan City 333411, Taiwan (R.O.C.)↗
Taoyuan City (10,976) · Guishan Dist. (1,601)

Listing

Listed (TWSE) (1,087) 1783

Organisation type

Company Limited by Shares

Founded

1998-12-03

Paid-in capital

NT$ 896,981,150

Representative

Lin Yung-hsieng

Phone

03-3287222

Website

https://mbi-bio.com/zh-hant/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$0.5–1B

Ownership

Group subsidiary / corporate-held · TCI CO., LTD.、FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION、Chung Chia Tou Tzu Fa Chan Co., Ltd.

North American market

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

Representative tenure

In office since 2021-09 (5 yrs); last handover 2021-09

Growth & profitability

Revenue 2026-09 YoY +35.3%, year-to-date +7.7%
Gross margin 69.2%, operating margin 28%, net margin 32% (2026-Q2 YTD)

Compliance record

FDA import refusal: 2 product(s), latest 2023-03-17

Certifications 49

• Medical device license (Class I) (1,430)Official registry Valid until 2029-03-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-05-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-07-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-11-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-12-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-06-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-05-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-05-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2021-01-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2019-11-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-11-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-11-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-09-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-02-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2023-03-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-01-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-09-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-04-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-04-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2023-12-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2021-08-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-06-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2031-10-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2027-08-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-09-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2023-12-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-07-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2029-04-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2029-04-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2029-04-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-04-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2031-10-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2027-02-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-04-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2031-08-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2030-05-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-07-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-06-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-09-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2030-02-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2021-08-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-06-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2030-05-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-06-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2031-12-24 · Taiwan Food and Drug Administration (TFDA)
• ISO 13485 (310)Self-reported

Processes & materials 3

• Ceramics (438) · InorganicSelf-reported
• Testing & inspection (1,056) · Assembly & inspectionSelf-reported
• Cleanroom production (392) · Assembly & inspectionSelf-reported

Patents 2

• 2023 Pharmaceutical composition for treating tendinitis and use thereof
• 2019 Bone implant composition with osteogenic capability and preparation method thereof

North American market evidence 7

• FDA 510(k) clearance K253989 2026-09-03
  HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)
• FDA 510(k) clearance K242100 2025-10-16
  SurgiAid Collagen Wound Dressing (HA)
• FDA 510(k) clearance K230529 2023-11-22
  HealiAid Dental Collagen Wound Dressing
• FDA 510(k) clearance K223126 2023-10-11
  SurgiAid® Collagen Wound Dressing
• FDA medical device registration 3004146122 2007-06-18 – 2025-11-26
  Wound Dressing With Animal-Derived Material(S); Filler, Bone Void, Calcium Compound; Bone Grafting Material, Animal Source and more (5)
• FDA import refusal 3004146122 2020-12-21 – 2023-03-17
  FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS); OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
• Health Canada medical device licence 194080

Recent changes 3

• 2026-05-30
  Certification expiryMedical device license (Class I) certificate expired on 2026-05-30
• 2026-05-24
  Certification expiryMedical device license (Class I) certificate expired on 2026-05-24
• 2026-05-13
  Certification expiryMedical device license (Class I) certificate expired on 2026-05-13

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 10

• ACARE TECHNOLOGY CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Testing & inspection, Medical device license (Class I), Medical device license (Class II), Medical device license (Class III)
• VASOBYPASS MEDICAL TECHNOLOGY CORPORATION · Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), ISO 13485
• NO.1 BIOTECHNOLOGY CO., LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Medical consumables wholesale
• T-PLUS IMPLANT TECH. CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), 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 II), 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 II), Medical device license (Class III)
• TAIWAN IMPLANT TECHNOLOGY CO., LTD. · Kaohsiung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Medical consumables wholesale
• SCIVISION BIOTECH INC. · Kaohsiung City Listed (TWSE) NT$0.5–1B
  Shared: Cleanroom production, Medical device license (Class I), Medical device license (Class III), ISO 13485
• SHANYOU BIOTECH MEDICAL DEVICE CO., LTD. · Taichung City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Medical consumables wholesale
• Rayfirst Healthcare CO., LTD. · Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Medical device license (Class III), Medical consumables wholesale

Open in advanced filters →