Unified Business No.

01456077

Industry

Computers, Electronics & Optical Products (2,116)

Main products

Radiation & electro-medical equipment (120)

Location

7F., NO. 1, ALY. 6, LN. 235, BAOQIAO RD., XINDIAN DIST., NEW TAIPEI CITY 231, TAIWAN, R.O.C.↗
New Taipei City (16,829) · Xindian Dist. (687)

Listing

Not publicly issued (84,625)

Registration status

Approved / Active

Organisation type

Company Limited by Shares

Founded

1985-08-06

Paid-in capital

NT$ 53,000,000

Representative

Kuo Yi-sung

Phone

02-26557810

Website

https://www.comdek.com/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$20–100M estimated

Ownership

Family-run (inferred)

North American market

FDA 510(k) clearance

Representative tenure

In office since at least 2013 (13+ years)

Certifications 27

• Medical device license (188)Official registry Valid until 2010-11-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2030-08-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2024-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class I) (1,430)Official registry Valid until 2027-10-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-08-04 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-10-06 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-09 · 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 2030-04-15 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-07-05 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-03-30 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-09 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-17 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-05-11 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-04-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-12 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-10-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-11-25 · Taiwan Food and Drug Administration (TFDA)
• CE Marking (162)Self-reported
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported
• ISO 9001 (4,293)Self-reported

Processes & materials 8

• Home Healthcare (3) · Extracted from websiteSelf-reported
• Emergency Care (2) · Extracted from websiteSelf-reported
• Non-invasive physiological measurement (1) · Extracted from websiteSelf-reported
• Carbon dioxide monitor (1) · Extracted from websiteSelf-reported
• Multifunction patient monitor (1) · Extracted from websiteSelf-reported
• Oxygen saturation meter (1) · Extracted from websiteSelf-reported
• Hematology analyzer (1) · Extracted from websiteSelf-reported
• Tunnel Blood Pressure Monitor (2) · Extracted from websiteSelf-reported

Patents 2

• 2025 Brain wave conduction sensor
• 2022 Gas concentration measurement system and airway adapter thereof

North American market evidence 1

• FDA 510(k) clearance K083351 2009-04-24
  PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P

Similar companies 9

• LILY MEDICAL CORPORATION · Miaoli County NT$20–100M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• PACIFIC HOSPITAL SUPPLY CO., LTD. · Miaoli County Listed (TPEx) NT$1–5B
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), CE Marking
• GEMMY INDUSTRIAL CORP. · New Taipei City < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• ENERGY RESOURCES INTERNATIONAL CO., LTD · Hsinchu County < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other merchandise wholesale brokerage n.e.c., Other medical devices & supplies manufacturing n.e.c.
• ZMI ELECTRONICS LTD. · Kaohsiung City NT$20–100M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), CE Marking
• EVERYWAY MEDICAL INSTRUMENTS CO., LTD. · New Taipei City NT$20–100M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), ISO 13485
• ROSSMAX INTERNATIONAL LTD. · Taipei City Listed (TPEx) NT$1–5B
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), ISO 13485
• PO YE X-RAY MFG. CORP. · New Taipei City < NT$20M estimated
  Shared: Medical device license, Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.
• ACOMED INDUSTRIAL CO., LTD. · New Taipei City < NT$20M estimated
  Shared: Medical device license (Class I), Medical device license (Class II), Other medical devices & supplies manufacturing n.e.c.

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