BIOPTIC INC.
光鼎生物科技股份有限公司
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2004Founded
NT$331MPaid-in capital
2Plants
5Certifications
1Patents
NT$100–500MRevenue band
- Unified Business No.
- 27352652
- Industry
- Computers, Electronics & Optical Products (2,116)
- Main products
- Radiation & electro-medical equipment (120)
- Location
- 4F., NO.108-3,MINQUAN RD., XINDIAN DISTRICT., NEW TAIPEI CITY,TAIWAN
New Taipei City (16,829) · Xindian Dist. (687) - Listing
- Emerging stock (TPEx) (359) 6850
- Registration status
- Approved / Active
- Organisation type
- Company Limited by Shares
- Founded
- 2004-08-16
- Paid-in capital
- NT$ 330,886,600
- Representative
- Tsai Shou-kuan
- Phone
- 02-2218-8726
- Website
- https://www.bioptic.com.tw
- Exporter
- Yes — registered with the Trade Administration
- Annual revenue band
- NT$100–500M
- Ownership
- Individually held
- North American market
- FCC equipment authorization FDA medical device registration
- Representative tenure
- In office since 2019-03 (7 yrs); last handover 2019-03
- Growth & profitability
- Revenue 2026-09 YoY +43.8%, year-to-date -0.1%
Gross margin 63.4%, operating margin 11.3%, net margin 13.7% (2026-Q2 YTD) - Compliance record
- FDA import refusal: 1 product(s), latest 2019-10-21
Plants 2
- Plant · No. 108-44F, 4F, No. 108-3, Minquan Rd., Xindian Dist., New Taipei City In production
- Xindian Plant 2 · 5F, No. 6, Ln. 130, Minquan Rd., Xindian Dist., New Taipei City In production
Certifications 5
- Medical device license (Class I) (1,430)Official registry Valid until 2028-12-04 · 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 2023-04-02 · Taiwan Food and Drug Administration (TFDA)
- GMP (261)Self-reported
- ISO 9001 (4,293)Self-reported
Processes & materials 7
- Nucleic acid analysis applications (1) · Extracted from websiteSelf-reported
- DNA & RNA samples (1) · Extracted from websiteSelf-reported
- Capillary electrophoresis analysis (1) · Extracted from websiteSelf-reported
- Molecular diagnostic reagent kit (1) · Extracted from websiteSelf-reported
- Nucleic acid extraction reagent (1) · Extracted from websiteSelf-reported
- Nucleic acid reagent consumables (1) · Extracted from websiteSelf-reported
- Biological fragment analyzer (1) · Extracted from websiteSelf-reported
Patents 1
- 2026 Sample tray for temperature-sensitive reaction
North American market evidence 3
- FCC equipment authorization 2AUQB 2019-10-01
- FDA medical device registration 3010030414 2022-12-20 – 2023-09-11
Clinical Sample Concentrator; Apparatus, Electrophoresis, For Clinical Use; General Purpose Reagent and more (5) - FDA import refusal 3010030414 2019-10-21
DNA GENETIC ANALYZER
Recent changes 1
- Certification expiryMedical device license (Class I) certificate expired on 2026-10-31
RSS feed · Recent changes at Taiwanese manufacturers →
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