PLEXBIO CO., LTD.

Unified Business No.

24489199

Industry

Pharmaceuticals & Medicinal Chemicals (273)

Main products

Pharmaceuticals & medicinal chemicals (276)

Location

6F.-1, No. 351, Yangguang St., Neihu Dist., Taipei City 11491, Taiwan (R.O.C.)↗
Taipei City (812) · Neihu Dist. (356)

Listing

Emerging stock (TPEx) (359) 6572

Organisation type

Company Limited by Shares

Founded

2009-12-17

Paid-in capital

NT$ 1,036,495,100

Representative

Tsao Ting

Phone

26275878

Website

https://www.plexbio.com/tw/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$100–500M

Ownership

Foreign-owned · Japan · Tien Hua Chu Shih Huei Enterprise (Japan)、DPTBiofundLLC (USA)

North American market

FDA medical device registration

Representative tenure

In office since at least 2013 (13+ years)

Growth & profitability

Revenue 2026-09 YoY -82.9%, year-to-date +51.1%
Gross margin 36.2%, operating margin -35.1%, net margin -28.4% (2026-Q2 YTD)

Compliance record

FDA import refusal: 1 product(s), latest 2020-06-04
Labour Standards Act penalties: 1 case(s) in 5 years, latest 2023-12-28, fines NT$ 100,000 (Art. 24) — matched by company name
Occupational safety penalties: 1 case(s) in 5 years, latest 2024-01-17 (Art. 12) — matched by company name

Certifications 14

• Medical device license (Class I) (1,430)Official registry Valid until 2030-08-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-02-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-01-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-01-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2026-10-31 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2023-06-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2022-03-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-10-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2018-08-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2028-03-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-05-14 · Taiwan Food and Drug Administration (TFDA)
• FDA (53)Self-reported
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported

Processes & materials 2

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

Patents 2

• 2025 Analyte labeling device and method
• 2024 Automated sample preparation system

North American market evidence 2

• FDA medical device registration 3009214950 2021-11-18
  Clinical Sample Concentrator
• FDA import refusal 3009214950 2020-06-04
  REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Recent changes 1

• 2026-10-31
  Certification expiryMedical device license (Class I) certificate expired on 2026-10-31

RSS feed · Recent changes at Taiwanese manufacturers →

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