Unified Business No.

28113005

Industry

Other Manufacturing (2,432)

Main products

Other electronic components (1,245)

Location

3F, NO.24-2, INDUSTRY E. RD. IV, HSINCHU SCIENCE PARK, HSINCHU, TAIWAN 30077↗
Hsinchu City (1,019) · East Dist. (401)

Listing

Listed (TWSE) (1,087) 6796

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

2010-08-05

Paid-in capital

NT$ 402,339,700

Representative

Cheng Chu-ming

Phone

03-5798860

Website

https://www.miis.com.tw/index.php?lang=tw

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$0.5–1B

Ownership

Individually held

North American market

FCC equipment authorization FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since at least 2013 (13+ years)

Growth & profitability

Revenue 2026-09 YoY +21.3%, year-to-date +18.8%
Gross margin 37.3%, operating margin -9.4%, net margin -7% (2026-Q2 YTD)

Plants 2

• Gong Plant 42 · 1F, No. 14, Gongye E. 4th Rd. (Hsinchu Science Park), East Dist., Hsinchu City↗ In production
• Dongsilu Dongsi Plant · 3F, No. 24-2, Gongye E. 4th Rd. (Hsinchu Science Park), East Dist., Hsinchu City↗ In production

Certifications 34

• Medical device license (Class I) (1,430)Official registry Valid until 2022-01-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-09-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2020-12-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-03-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2025-07-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-04-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2031-04-20 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-09-07 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2017-01-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-11-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-01-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-02-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-02-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-02-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-02-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2029-02-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-04-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2021-12-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-08-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-08-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-07-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2024-07-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2025-07-08 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2024-04-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-11-25 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-05-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2022-07-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-06-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-06-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-09-13 · Taiwan Food and Drug Administration (TFDA)
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported

Processes & materials 3

• Injection Molding (497) · FormingSelf-reported
• Mould design & manufacturing (644) · MachiningSelf-reported
• Assembly (901) · Assembly & inspectionSelf-reported

Patents 41

• 2026 Fundus imaging system
• 2026 Miniaturized image sensing illumination package and manufacturing method thereof
• 2026 Endoscope and steel cable fixing device

North American market evidence 6

• FCC equipment authorization 2AFB3 2015-07-07
• FDA 510(k) clearance K253217 2025-12-23
  MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
• FDA 510(k) clearance K234113 2024-05-01
  MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
• FDA 510(k) clearance K214050 2022-07-01
  ENT Nasopharyngoscope and Accessories
• FDA 510(k) clearance K170470 2017-10-06
  Digital Eye Anterior Camera
• FDA medical device registration 3015316279 2011-08-23 – 2026-03-18
  Camera, Ophthalmic, Ac-Powered; Tonometer, Ac-Powered; Biomicroscope, Slit-Lamp, Ac-Powered and more (21)

Public registers of the US FDA, the FCC and Health Canada, matched on the registered English name. An FDA import refusal is a negative record, but also shows goods actually shipped to the US. The FCC dataset ends in 2021.

Government programs & awards 1

• Startup Award – Silver Award 2012 · Ministry of Economic Affairs Small & Medium Enterprise and Startup Administration

Similar companies 10

• ROLENCE ENTERPRISE INC. · Taoyuan City NT$20–100M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• OMNIMATE ENTERPRISE CO., LTD. · Yilan County < NT$20M estimated
  Shared: Mould design & manufacturing, Medical device license (Class I), Medical device license (Class II), GMP
• ADVANCED MEDICAL DESIGN CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Assembly, Medical device license (Class I), Medical device license (Class II), ISO 13485
• BioVanguard CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Injection Molding, Mould design & manufacturing, Assembly, Medical device license (Class I)
• SUNDER BIOMEDICAL TECH. CO., LTD. · Yunlin County Emerging stock (TPEx) NT$0.5–1B
  Shared: Injection Molding, Assembly, Medical device license (Class I), Medical device license (Class II)
• MIN AIK TECHNOLOGY CO., LTD. · Taoyuan City Listed (TWSE) NT$1–5B
  Shared: Injection Molding, Mould design & manufacturing, Assembly, Medical device license (Class II)
• AGNITIO SCIENCE & TECHNOLOGY, INC. · Hsinchu County Public company (unlisted) NT$20–100M
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• GE FONG INDUSTRY CO., LTD. · Kaohsiung City < NT$20M estimated
  Shared: Injection Molding, Mould design & manufacturing, Assembly
• HMD BIOMEDICAL INC. · Hsinchu County Public company (unlisted) NT$100–500M
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485
• PEGAVISION CORPORATION · Taoyuan City Listed (TWSE) ≥ NT$5B
  Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485

Ranked by overlap in processes and materials, registered business activities, certifications and main products; rarer shared traits weigh more. Dissolved companies are excluded.

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