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ST. SHINE OPTICAL CO., LTD.

精華光學股份有限公司

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1986Founded

NT$504MPaid-in capital

7Plants

232Certifications

1Patents

NT$1–5BRevenue band

Unified Business No.: 22195654
Industry: Other Manufacturing (2,432)
Main products: Medical devices & supplies (878)
Location: 5 F., No. 276-2, Sec. 1, Datong Rd., Xizhi Dist., New Taipei City 221461, Taiwan (R.O.C.)
New Taipei City (16,829) · Xizhi Dist. (1,300)
Listing: Listed (TPEx) (890) 1565
Registration status: Approved / Active
Organisation type: Company Limited by Shares
Founded: 1986-09-24
Paid-in capital: NT$ 504,165,160
Representative: Chen Ming-hsien
Phone: (02)8691-6000
Website: https://www.stshine.com.tw/
Exporter: Yes — registered with the Trade Administration
Annual revenue band: NT$1–5B
Ownership: Group subsidiary / corporate-held · Yun Ming Tou Tzu Co., Ltd.、Pao Ta Co., Ltd.
North American market: FDA 510(k) clearance FDA medical device registration Health Canada medical device licence
Representative tenure: In office since at least 2015 (11+ years)
Growth & profitability: Revenue 2026-09 YoY -6.3%, year-to-date -15.3%
Gross margin 18.9%, operating margin 9.6%, net margin 8.5% (2026-Q2 YTD)
Compliance record: FDA import refusal: 1 product(s), latest 2019-10-23
Environmental penalties: 2 case(s) in 5 years, latest 2024-03-29, fines NT$ 66,000 (industrial waste)
Labour Standards Act penalties: 6 case(s) in 5 years, latest 2026-06-17, fines NT$ 4,400,000, 2 major (Art. 32) — matched by company name
Occupational safety penalties: 2 case(s) in 5 years, latest 2024-03-07, fines NT$ 60,000 (Art. 6) — matched by company name

Plants 7

Wudu Plant · 3F, 4F, 5F, 6F, 2F, No. 46, 46, Dunan St., Qidu Dist., Keelung City In production
Plant · No. 2765, 9F, No. 276-22, 3, 4, 5, 6, 9F, 1, 2, 5F, No. 276-1, Sec. 1, Datong Rd., Xizhi Dist., New Taipei City In production
Yatai Plant · 308-6, 7, 8, 9, No. 104F, 3F, No. 308-6, 7, 8, 9, 10, Sec. 1, Datong Rd., Xizhi Dist., New Taipei City In production
Taike Plant · 3F-6, 4F-1, 5F-1, 6F-1, 8F-1, 8F-6, 3F-1, No. 239, Sec. 1, Datong Rd., Xizhi Dist., New Taipei City In production
Kangning Plant · Fu 2F Zhi 7F, No. 147-1, No. 147-2, No. 147, Kangning St., Xizhi Dist., New Taipei City In production
Xizhi Plant 2 · 12F, No. 306-34F, 7F, 12F, No. 3067F-2, -3, 9F, No. 306, Sec. 1, Datong Rd., Xizhi Dist., New Taipei City In production
Xike Plant · No. 935F-1, 2, 3, 5, 6, 7, No. 936F, No. 936F-1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 12, No. 955F-1, 2, 3, 5, No. 956F, No. 956F-1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 12, 5F, No. 93, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City In production

Certifications 232

Medical device license (188)Official registry Valid until 2001-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (188)Official registry Valid until 2003-06-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (188)Official registry Valid until 2014-10-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-06-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-09-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-02-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-06-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-06-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-06-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-07-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-08-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-03-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-03-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-10-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-10-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-10-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2025-11-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-11-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2025-11-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-11-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-11-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-11-16 · 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 2030-11-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-12-04 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-12-04 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-07-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-07-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-07-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-05-04 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-12-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-09-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-05-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-02-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-01-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-05-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-05-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-05-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-11-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-02-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-11-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-02-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-10-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-11-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-11-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-10-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-07-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-11-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-11-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-02-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-03-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-05-25 · 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 2028-06-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-06-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-06-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-06-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-07-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-07-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-07-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-08-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-09-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-05-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-07-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2019-11-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-10-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-11-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-07-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-02-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-01-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-02-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-03-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-04-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-10-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-10-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-06-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-09-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-09-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2020-12-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-06-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-11-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-11-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-07-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-11-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-06-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-09-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-10-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-09-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-09-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-04-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-05-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-06-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-06-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-06-11 · 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 2021-07-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-06-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-07-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-04-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2025-04-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2025-04-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2025-04-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-04-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-02-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-03-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-03-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-04-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-04-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-04-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-04-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-04-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-04-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-04-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-06-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-07-31 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-09-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-01-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-02-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-02-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-02-17 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-09-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-03-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-03-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-12-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-11-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-01-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-04-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-04-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-11-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-03-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-03-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2020-12-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-09-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-02-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-11-03 · 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 2026-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-03-16 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-09-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-02-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2026-03-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-03-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-12-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-01-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-01-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-01-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-01-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-19 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-25 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-02-27 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-02-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-31 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-03-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2029-04-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-04-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-09-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-04-06 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2024-11-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-06-05 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-12-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2023-09-11 · Taiwan Food and Drug Administration (TFDA)
CE Marking (162)Self-reported
GMP (261)Self-reported
ISO 13485 (310)Self-reported

Processes & materials 1

Injection Molding (497) · FormingSelf-reported

Patents 1

2023 Vision correction optical lens

North American market evidence 11

FDA 510(k) clearance K254269 2026-03-19
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
FDA 510(k) clearance K250364 2025-10-07
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
FDA 510(k) clearance K240477 2024-07-01
Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
FDA 510(k) clearance K162317 2016-10-21
Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens
FDA 510(k) clearance K132146 2013-08-30
SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)
FDA 510(k) clearance K123484 2013-03-29
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k) clearance K121201 2012-10-26
SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k) clearance K092852 2010-03-11
SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
FDA medical device registration 9617499 2002-08-24 – 2026-07-06
Lenses, Soft Contact, Daily Wear; Lens, Contact, (Disposable)
FDA import refusal 3003714643 2019-10-23
LENSES, SOFT CONTACT, EXTENDED WEAR
Health Canada medical device licence 125013

Recent changes 9

2027-02-03
Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2027-02-03
2027-01-25
Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2027-01-25
2026-12-23
Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-12-23
2026-10-28
Certification expiryMedical device license (Class II) certificate expired on 2026-10-28
2026-06-17
PenaltiesLabour Standards Act penalties: latest case 2026-06-17; 6 case(s) in 5 years, fines NT$ 4,400,000
2026-06-05
Certification expiryMedical device license (Class II) certificate expired on 2026-06-05
2026-03-11
Certification expiryMedical device license (Class II) certificate expired on 2026-03-11
2025-11-12
Certification expiryMedical device license (Class II) certificate expired on 2025-11-12
2025-11-06
Certification expiryMedical device license (Class II) certificate expired on 2025-11-06

RSS feed · Recent changes at Taiwanese manufacturers →

Similar companies 10

UNICON OPTICAL CO., LTD. · Hsinchu County Emerging stock (TPEx) NT$0.5–1B
Shared: Medical device license, Medical device license (Class II), ISO 13485, Other merchandise wholesale brokerage n.e.c.
WELL VISION ENTERPRISE CO., LTD. · Yilan County NT$20–100M estimated
Shared: Medical device license, Medical device license (Class II), Eyewear & parts wholesale, Eyewear manufacturing
I-SEE VISION TECHNOLOGY INC. · Hsinchu City NT$100–500M estimated
Shared: Medical device license, Medical device license (Class II), Eyewear & parts wholesale, Eyewear manufacturing
FREE BIONICS TAIWAN INC. · Hsinchu City < NT$20M estimated
Shared: Medical device license (Class II), CE Marking, GMP, ISO 13485
ROLENCE ENTERPRISE INC. · Taoyuan City NT$20–100M estimated
Shared: Medical device license (Class II), CE Marking, GMP, ISO 13485
YUNG SHENG OPTICAL CO., LTD. · Taichung City NT$1–5B estimated
Shared: Medical device license, Medical device license (Class II), Eyewear & parts wholesale, Eyewear manufacturing
SMART PERFORMER CO., LTD. · New Taipei City NT$20–100M estimated
Shared: Medical device license (Class II), Eyewear & parts wholesale, Eyewear manufacturing
MOULDEX CO., LTD. · Hsinchu County NT$20–100M estimated
Shared: Injection Molding, Medical device license, Medical device license (Class II), ISO 13485
SUNDER BIOMEDICAL TECH. CO., LTD. · Yunlin County Emerging stock (TPEx) NT$0.5–1B
Shared: Injection Molding, Medical device license, Medical device license (Class II), CE Marking
MESURE TECHNOLOGY CO., LTD. · New Taipei City NT$20–100M estimated
Shared: Medical device license, Medical device license (Class II), ISO 13485

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