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Certified Quality


ISO 13485:2016 ISO 9001:2015 MDD9342EEC
CMDCAS GMP CERTIFICATE OF GOOD DESIGN PRODUCT

Quality Improvement

Quality Assurance

Quality Service

Certificates of Blackbodies

Certification of RII blackbody (download )
Certification of EU EN12470-5 Blackbody (download )
The Performance Comparison Table of RII and EN12470-5 Blackbodies( download)
* The Performance Comparison Table of RII and EN12470-5 Blackbodies
By: Frank Lin, 12/10/2004

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.
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Milestone

  
2012
Q4 Radiant THPX9J、THP59JU series IET(Infrared Ear Thermometer) has obtained Taiwan product registration
Q1 Radiant Innovation Inc. has obtained P.R.C.(The People's Republic of China) CMC certificate
2009
Q4 Radiant Temperature Calibration Laboratory was certified by TAF
Q1 Radiant TH52Z (Infrared Multi-Function Thermometer) obtained CANADA Medical Device Licence (78858)
2008
Q2 TCT30 Series obtained NSF approval (4R160-01 / 4R161-01).
Q1 TH6 Series obtained CANADA Medical Device License (76199).
2007
Q2 TH01BN obtained FDA approval (K070976).
  TH5 Series obtained Taiwan product registration.
2006
Q4 TH5 Series obtained CANADA Medical Device License (72498).
  TH5 series obtained FDA approval (K063185).
Q3 TH00 Series obtained Taiwan product registration.
2005
Q4 China plant obtained Taiwan QSD certificate.
Q3 TH00 series obtained FDA approval (K051269).
  TH8 Series conform to the requirement of WEEE 2002/96/EC Artical 7-Recovery (10014078001).
  TN4 Series conform to the requirement of WEEE 2002/96/EC Artical 7-Recovery (10014077001).
Q2 TH00X series obtained CANADA Medical Device Licence (68334).
2004
Q4 Radiant Innovation infrared ear/forehead thermometer obtained Taiwan product registration.
Q3 TH05F and TH06F obtained CANADA Medical Device Licence (65574).
  THXXN Series obtained FDA approval (K040377).
Q2 Taiwan plant obtained Taiwan GMP certificate.
Q1 Taiwan/ China plant obtained Canada CMDCAS certificate (74 500 2402).
  Taiwan/ China 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).
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).
  TH109 obtained the "Symbol of Excellence Awards" from Taiwan government.
  TN105 obtained the "Symbol of Excellence Awards" from Taiwan government.
  TH109 obtained FDA approval (K030324).
2002
Q4 TH839 obtained FDA approval (K011059).
  TN105 obtained "CERTIFICATE OF GOOD DESIGN PRODUCT" from Taiwan government.
Q2 China plant obtained ISO 13485:1996 certificate.
  China plant obtained ISO 9001:1994 certificate.
Q1 Taiwan plant obtained ISO 13485:1996 certificate.
  Taiwan plant obtained ISO 9001:1994 certificate.
  TH809 obtained the "Symbol of Excellence Awards" form Taiwan government.
  TH889 obtained FDA approval (K020504).
2001
Q3   TH809 obtained FDA approval (K011059).
Q1   Taiwan plant obtained ISO 13485:1996 certificate.
    Taiwan plant obtained ISO 9001:1994 certificate.
2000
Q3   Radiant Innovation Inc. was established on Jun. 28, 2000
 
 
 
Radiant Innovation Inc. was established in year 2000 and mainly focus on Infrared Technology. Our RD, QA, Manufacture Team have been in this field for more than 20 years. Therefore, we are able to provide high-quality & good-design products to all of our customers in the world. There are three product-lines in Radiant in the moment.

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