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

 
Accreditation Criteria: ISO/IEC 17025 : 2005
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Accreditation Number: 2147
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Calibration Items: KE1007 Radiation Thermometer
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  KE1002 Platinum Resistance Thermometer
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Reliability Assurance Test Plan


Quality Policy

     

Milestone

2012

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) obtained CANADA Medical Device License.

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
  • TCT23N 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, have  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, comply with 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, comply with 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, comply with EMC test (AE 50015319 0001).
  • TH1 series, comply with EMC test (AK 50017377 0001).
  • TH1 series, comply with Safety test (TA 50003274 03).
  • TH0 series, comply with 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, comply with EMC test (AK 50024747 0001).
  • TH0 series, comply with 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, comply with EMC test (AK 50008727 0001).
  • TH8 series, comply with 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

Certified Quality

ISO 9001:2015

TIC (Taiwan Incorporation Competition)

CERTIFICATE OF GOOD DESIGN PRODUCT

Quality Improvement

Quality Assurance

Quality Service

Founded in July 2000, ZyTemp belongs to world-class Infrared Technology-oriented thermometer manufacturer - Radiant Innovation Inc. and become a premier provider of infrared temperature measurement devices. Originally started from a professional team of engineers specializing in infrared thermometry, this company is now emerging as worldwide well-known manufacturer of infrared thermometers (IRT).

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