Capability

Certified Quality

TH Certified Quality
  • ISO 13485:2016
  • CE 1639
  • FDA (U.S. Food and Drug Administration)
  • KGMP (Korea)
  • PMDA (Japan)
  • Brazil INMETRO
  • TFDA (Taiwan Food and Drug Administration)
TN Certified Quality
  • ISO 9001:2015
  • CE
  • NSF(National Sanitation Foundation)
  • FDA Laser
  • JQA Laser

Certificates of Blackbodies

The performance of RII design type Blackbody is better than EN12470-5 type Blackbody.

  • Certification of RII blackbody
  • Certification of EU EN12470-5 Blackbody
  • The Performance Comparison Table of RII and EN12470-5 Blackbodies

*The Performance Comparison Table of RII and EN12470-5 Blackbodies
By: Frank Lin, 12/10/2004

  RII Design Type EN 12470-5 Type Deviation
tPt (°C) tsr-tPt (°C) tse-tPt (°C) tsr-tse (°C)
29 -0.004 -0.007 0.003
34 -0.011 -0.013 0.002
37 -0.008 -0.017 0.009
41 -0.019 -0.022 0.003
43 -0.011 -0.013 0.002
Average -0.0106 -0.0144 0.0038

Where;
(1) tPt is measured with platinum resistance thermometer which provides the bath temperature.
(2) tse is measured with an infrared radiaton ear thermometer which provides the radiation temperature of RII design type Blackbody.
(3) tsr is measured with an infrared radiaton ear thermometer which provides the radiation temperature of EN12470-5 type Blackbody.

Bath Temperature

2000
Q3
  • Radiant Innovation Inc. was established on Jun. 28, 2000
2001
Q3
  • Radiant obtained FDA approval (K011059).
Q1
  • Taiwan plant obtained ISO 13485 certificate.
  • Taiwan plant obtained ISO 9001 certificate.
  • Radiant obtained CE approval (HD 60005278 0001).
2002
Q1
  • Radiant passed EMC test (AK 50008727 0001).
  • Radiant passed Safety test (TA 50003274 02).
2003
Q4
  • Taiwan plant obtained Canada CMDCAS certificate (74 500 2402).
  • China plant obtained Canada CMDCAS certificate (74 500 2402).
Q2
  • China plant upgraded ISO 9001 to version 2000 (01 100 008852).
Q1
  • Taiwan plant upgraded ISO 9001 to version 2000 (01 100 008852).
2004
Q4
  • Radiant Innovation infrared ear/forehead thermometer obtained Taiwan GMP medical device registration.
  • Radiant Innovation Inc., all series, infrared ear/forehead thermomter products, passed the newest EMC version: EN 60601-1-2:2001.
Q3
  • Infrared Forehead Thermometer obtained CANADA Medical Device Licence.
Q2
  • Taiwan plant obtained Taiwan GMP certificate.
  • China plant upgraded ISO 13485 to version 2003 (SY 60008246 0001).
Q1
  • Taiwan plant upgraded ISO 13485 to version 2003 (SY 60008246 0001).
  • Infrared Ear Thermometer obtained CANADA Medical Device Licence (63558).
  • Infrared Forehead Thermometer obtained CANADA Medical Device Licence (63559).
2005
Q4
  • China plant obtained Taiwan GMP certificate.
2009
Q4
  • Radiant Temperature Calibration Laboratory was certified by TAF
Q1
  • Radiant TH52Z (Infrared Ear Thermometer) has been certificated by Canada CMDCAS
2012
Q1
  • Radiant Innovation Inc. has obtained P.R.C.(The People's Republic of China) CMC certificate
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