FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION

Unified Business No.

80539426

Industry

Pharmaceuticals & Medicinal Chemicals (278)

Main products

Basic chemical materials (359)

Location

9 F.-1, No. 380, Sec. 6, Nanjing E. Rd., Shitan Vil., Neihu Dist., Taipei City 114030, Taiwan (R.O.C.)↗
Yilan County (1,016) · Jiaoxi Township (43)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2003-11-10

Paid-in capital

NT$ 1,665,564,950

Representative

Chang Ming-te

Phone

02-2712-2211

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$1–5B estimated

Ownership

Group subsidiary / corporate-held · FORMOSA CHEMICALS AND FIBRE CORPORATION

North American market

FDA medical device registration

Representative tenure

In office since at least 2014 (12+ years)

Compliance record

FDA import refusal: 1 product(s), latest 2020-09-29

Plants 2

• Yilan Plant · No. 3, Longquan Rd., Jiaoxi Township, Yilan County↗ In production
• Plant · No. 359, Sec. 3, Zhongshan Rd., Changhua City, Changhua County↗ In production

Certifications 99

• Eco-label (Green Mark) (589)Official registry · Ministry of Environment
• Medical device license (Class I) (1,430)Official registry Valid until 2029-12-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-01-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-03-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-08-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-05-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-09-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-07-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-05-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-02-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-10-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-09-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-09-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-09-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-10-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-10-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-03-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-03-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-08-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-03-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-03-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-05-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-02-27 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-05-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-04-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-08-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-08-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-08-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-11-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-11-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-12-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-10-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-08-31 · 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 II) (794)Official registry Valid until 2029-07-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-08-04 · 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 2029-05-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-03-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2024-03-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2024-03-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-08-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-08-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-04-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-06-02 · 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 2030-06-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-07-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-11-12 · 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 2031-02-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2026-02-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2011-04-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-04-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-06-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-08-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-08-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-14 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-11-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-12-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-01-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2016-12-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-01-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-05-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-07-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-04-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-02-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-03-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-08-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-01-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2010-12-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-04-22 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2013-11-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2011-05-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2018-06-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-02-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2025-11-03 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-12-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2030-06-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class III) (94)Official registry Valid until 2028-11-08 · Taiwan Food and Drug Administration (TFDA)

Patents 4

• 2026 Pharmaceutical composition and use thereof in treating dermatitis
• 2025 Onion extract, preparation method thereof and use thereof in promoting hair growth
• 2025 Method for recovering metal from waste catalyst using heating technology

North American market evidence 2

• FDA medical device registration 3007699035 2009-06-02 – 2014-07-13
  Filler, Bone Void, Calcium Compound; Dispenser, Cement; Mixer, Cement, For Clinical Use
• FDA import refusal 3007699035 2020-09-29
  REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Recent changes 9

• 2027-01-10
  Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2027-01-10
• 2026-05-23
  Certification expiryMedical device license (Class I) certificate expired on 2026-05-23
• 2026-03-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-03-31
• 2026-03-30
  Certification expiryMedical device license (Class I) certificate expired on 2026-03-30
• 2026-02-08
  Certification expiryMedical device license (Class II) certificate expired on 2026-02-08
• 2025-11-11
  Certification expiryMedical device license (Class I) certificate expired on 2025-11-11
• 2025-11-03
  Certification expiryMedical device license (Class III) certificate expired on 2025-11-03
• 2025-10-26
  Certification expiryMedical device license (Class I) certificate expired on 2025-10-26
• 2025-10-19
  Certification expiryMedical device license (Class I) certificate expired on 2025-10-19

RSS feed · Recent changes at Taiwanese manufacturers →

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