Pursoe Profits Starting from Superior Customer Satisfaction

Certified Quality

TH Certified Quality

  • CMC Certificate : ()05830034-2
  • Certificate of Temperature Calibration Laboratory of TAF (Taiwan Accreditation Foundation)
  • Quality System : ISO 13485:2003, MDD 93/42/EEC, CMDCAS ISO 13485:2003, Taiwan GMP
  • PTB Certificate : EN12470-5:2003, RII Black Body
  • FDA Approval : TH8 Series, TH88 Series, THXXN Series, TH00XY Series, TH5XY Series, TH01BN, TH60N, TH709, THP Series
  • CANADA Certificate : TH8 Series (63558) , THXXF (63559) , TH0XF (65574) , TH00 Series (68334) , TH5XY Series (72498),   
      TH60XY Series (76199 ), TH52Z (78858)
  • Taiwan Manufacture & Free Sales Certificate : TH0XF Series, TH8 Series, TH00 Series, TH5XY Series, TH709, THPX9J, THP59JU
      PC7200, PC840
  • EMC EN 60601-1-2: All Series
  • Safety EN 60601-1: All Series
  • WEEE 2002/96/EC Article7-Recovery : TH889E

TN/ TCT/ ZF/ DD/ ZG Certified Quality

  • CMC Certificate : (苏)制05830034-1号
  • GOOD DESIGN PRODUCT: TN105, TN105i2
  • Certificate of Temperature Calibration Laboratory of TAF (Taiwan Ac creditation Foundation)
  • NSF: TCT303 series
  • Quality System : ISO 9001:2008
  • FDA Laser : for TN with Laser
  • EMC EN 61326 : All Series
  • JQA Certificate : TN403L
  • WEEE 2002/96/EC Article 7-Recovery : TN408LC

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.
------------------------------------------------------------------------------------------------------------------------------------------

Certificate of Temperature Calibration Laboratory of TAF (Taiwan Accreditation Foundation)

                  

  • Accreditation Criteria: ISO/IEC 17025 : 2005
  • Accreditation Number: 2147
  • Calibration Items: KE1007 Radiation Thermometer
                                     KE1002 Platinum Resistance Thermometer

Radiation Thermometer

  • Ranges:  (34 to 43) °C <Medical Thermometers>
  • Best measurement Capability:  0.06 °C

Platinum Resistance Thermometer

  • Ranges: (-30 to 0) °C
    Ranges: (5 to 80) °C
    RaRa1nges: (100 to 200) °C
  • Best measurement Capability: 0.048 °C
    Best measurement Capability: 0.028 °C
    Best measurement Capability: 0.046 °C

Milestone

2012
Q4 Radiant THPX9J、THP59JU series IET(Infrared Ear Thermometer) has obtained Taiwan GMP certificate
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 Ear Thermometer) has been certificated by Canada CMDCAS
2008
Q2 TCT30 Series obtained NSF approval (4R160-01 / 4R161-01).
Q1 TH6 Series obtained CANADA Medical Device License (76199).
  TN01U, comply with EMC test (AE 50125069 0001).
2007
Q4 TN92S, comply with EMC test (AE 50121195 0001).
  TN185, comply with EMC test (AE 50118150 0001).
  DD106, comply with EMC test (AE 50118149 0001).
Q3 TN80 Series, comply with EMC test (AE 50118064 0001).
  TCT01 Series, comply with EMC test (AE 50112266 0001).
Q2 TH01BN obtained FDA approval (K070976).
  TH5 Series obtained Taiwan GMP medical device registration.
  TH6 Series, comply with Safety test (AK 50108575 0001).
  TH6 Series, comply with EMC test (AK 50106885 0001).
  TN43 Series, comply with EMC test (AE 50107887 0001).
  ZG106, comply with EMC test (AE 50107440 0001).
Q1 TH01 Series, comply with EMC test (AK 50102556).
  TH01 Series, comply with Safety test (AK 50102480 0001).
  TN42 Series, comply with EMC test (AE 50102477 0001).
2006
Q4 TH5 Series obtained CANADA Medical Device License (72498).
  TH5 series obtained FDA approval (K063185).
  TNF0 Series, comply with EMC test (AE 50097392 0001).
  TN25 Series, comply with EMC test (AE 50096237 0001).
Q3 TH00 Series obtained Taiwan GMP medical device registration.
  TH5 Series, comply with Safety test (AK 50089283 0001).
  TN41 Series, comply with EMC test (AE 50092680 0001).
Q2 TH5 Series, comply with EMC test (AK 50084757).
Q1 T8 series, comply with EMC test (AK 50077138 0001).
  TH2 series, comply with EMC test (AK 50077115 0001).
  TH00 series, comply with EMC test (AK 50053992 0001).
  TH2 series, comply with Safety test (TA 50078707 01).
  TH00 series, comply with Safety test (TA 50054675 01).
2005
Q4 TCT00 Series, comply with EMC test (AE 50076496 0001).
  TCT30 Series, comply with EMC test (AE 50074966 0001).
  China plant obtained Taiwan GMP 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 Infrared Forehead Thermometer obtained CANADA Medical Device Licence (68334).
Q1 TCT23 Series, comply with EMC test (AE 50054806 0001).
  TH0 series, comply with Safety test (AK 50053992 0001).
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 (65574).
  THXXN Series obtained FDA approval (K040377).
  TN10 Series, comply with EMC test (AE 50046258 0001).
  TN00 Series, comply with EMC test (AE 50046260 0001).
  TN30 Series, comply with EMC test (AE 50045041 0001).
Q2 Taiwan plant obtained Taiwan GMP certificate.
  China plant obtained Canada CMDCAS certificate (74 500 2402).
  China plant upgraded ISO 13485 to version 2003 (SY 60008246 0001).
  TH05F obtained CE approval (HD 60005278 0001).
  TN15 series, comply with EMC test (AE 50043098 0001).
  TN3 series, comply with EMC test (AE 50045041 0001).
Q1 Taiwan plant obtained Canada CMDCAS certificate (74 500 2402).
  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).
  TNT series, comply with EMC test (AE 50040217 0001).
2003
Q4 Taiwan plant obtained Canada CMDCAS certificate (74 500 2402).
  China plant obtained Canada CMDCAS certificate (74 500 2402).
Q3 TH03F obtained CE approval (HD 60005278 0001).
Q2 China plant upgraded ISO 9001 to version 2000 (01 100 008852).
  TCT1 series passed EMC test (AE 50025415 0001).
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.
  TN2 series passed EMC test (AE 50023801 0001).
  TH109 obtained FDA approval (K030324).
2002
Q4 TH109 obtained CE approval (HD 60005278 0001).
  TH839 obtained CE approval (HD 60005278 0001).
  TH839 obtained FDA approval (K011059).
  TN105 obtained "CERTIFICATE OF GOOD DESIGN PRODUCT" from Taiwan government.
Q3 TN1 series passed EMC test (AE 50015319 0001).
  TH1 series passed EMC test (AK 50017377 0001).
  TH1 series passed Safety test (TA 50003274 03).
  TH0 series passed Safety test (TA 50003274 05).
Q2 China plant obtained ISO 13485:1996 certificate.
  China plant obtained ISO 9001:1994 certificate.
  TH889 obtained CE approval (HD 60005278 0001).
  TH1 series passed EMC test (AK 50024747 0001).
  TH0 series passed EMC test (AK 50030585 0001).
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).
  TH8 series passed EMC test (AK 50008727 0001).
  TH8 series passed Safety test (TA 50003274 02).
2001
Q3   TH809 obtained FDA approval (K011059).
Q1   Taiwan plant obtained ISO 13485:1996 certificate.
    Taiwan plant obtained ISO 9001:1994 certificate.
    TH809 obtained CE approval (HD 60005278 0001).
2000
Q3   Radiant Innovation Inc. was established on Jun. 28, 2000