RADIANT INNOVATION INC.

Unified Business No.

70590078

Industry

Computers, Electronics & Optical Products (2,116)

Main products

Radiation & electro-medical equipment (120)

Location

1F, NO.3, INDUSTRY E 9TH RD., SCIENCE-BASED INDUSTRIAL PARK., HSINCHU SCIENCE PARK, HSINCHU COUNTY, TAIWAN, R.O.C.↗
Hsinchu County (1,617) · Baoshan Township (72)

Listing

Listed (TPEx) (890) 3373

Organisation type

Company Limited by Shares

Founded

2000-06-28

Paid-in capital

NT$ 476,187,820

Representative

Chou Chih-yuan

Phone

03-6111666

Website

https://www.radiantek.com.tw/ch/investors/article-detail/management/

Exporter

Yes — registered with the Trade Administration

Annual revenue band

NT$100–500M

Ownership

Individually held

North American market

FDA 510(k) clearance FDA medical device registration

Representative tenure

In office since 2019-01 (7 yrs); last handover 2019-01

Growth & profitability

Revenue 2026-09 YoY +24.8%, year-to-date +10.3%
Gross margin 16.6%, operating margin -13.5%, net margin -7.7% (2026-Q2 YTD)

Certifications 27

• Medical device license (188)Official registry Valid until 2009-09-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2022-07-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-05-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-08-26 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-02 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-01-28 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-10-13 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-10 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-03-24 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-04-18 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-06-21 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-03-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-08-19 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-10-23 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2030-12-27 · 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 2023-01-16 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2031-11-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2029-09-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2024-09-29 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2028-10-01 · Taiwan Food and Drug Administration (TFDA)
• Medical device license (Class II) (794)Official registry Valid until 2027-01-27 · Taiwan Food and Drug Administration (TFDA)
• CE Marking (162)Self-reported
• FDA (53)Self-reported
• GMP (261)Self-reported
• ISO 13485 (310)Self-reported
• ISO 9001 (4,293)Self-reported

Processes & materials 4

• Optoelectronics (337) · Company nameSelf-reported
• Home healthcare products (1) · Extracted from websiteSelf-reported
• Infrared ear & forehead thermometer (1) · Extracted from websiteSelf-reported
• Non-contact infrared thermometer (1) · Extracted from websiteSelf-reported

Patents 24

• 2026 Ear cushion dispensing device
• 2024 Temperature measuring device
• 2024 Dual-purpose temperature measuring device

North American market evidence 14

• FDA 510(k) clearance K240648 2024-06-05
  Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
• FDA 510(k) clearance K163601 2018-12-06
  RII Smart IR Thermometer
• FDA 510(k) clearance K162083 2017-01-09
  RII Multi-function Infrared Thermometer, Model TH52Z
• FDA 510(k) clearance K121428 2012-07-17
  NON-CONTACT CLINICAL THERMOMETER
• FDA 510(k) clearance K111637 2011-12-06
  INFRARED EAR THERMOMETER
• FDA 510(k) clearance K103097 2010-12-29
  INFRARED EAR THERMOMETER
• FDA 510(k) clearance K102187 2010-12-10
  RII INFRARED EAR THERMOMETER,
• FDA 510(k) clearance K101253 2010-06-29
  RII INFRARED EAR THERMOMETER, MODEL: TH60N
• FDA 510(k) clearance K070976 2007-04-20
  RII INFRARED EAR THERMOMETER, MODEL TH01BN
• FDA 510(k) clearance K063185 2006-11-17
  RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES
• FDA 510(k) clearance K051269 2005-09-09
  RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES
• FDA 510(k) clearance K040377 2004-09-16
  RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
• FDA 510(k) clearance K030324 2003-02-27
  RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES
• FDA medical device registration 9710548 2007-11-25 – 2025-09-08
  Continuous Measurement Thermometer; Clinical Electronic Thermometer

Recent changes 1

• 2027-01-27
  Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2027-01-27

RSS feed · Recent changes at Taiwanese manufacturers →

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