| |
2007 |
| Q2 |
 |
TH01BN has obtained FDA approval (K070976) |
| Q1 |
 |
TH5 series has obtained CE approval (HD 60014693 0001) |
| |
2006 |
| |
 |
Infrared Ear Thermometer has obtained CANADA Medical Device Licence (72498) |
Q4 |
 |
TH5 Series has obtained FDA approval (K063185) |
| |
 |
Taiwan plant has updated ISO 13458:2003 certificate (SX 60014694 0001) |
| |
 |
Taiwan plant has updated ISO 9001:2000 certificate (SY 60014695 0001) |
| |
 |
Taiwan plant has updated Canada CMDCAS certificate (74 500 2402) |
| |
 |
TH00 series has obtained CE approval (HD 60014693 0001) |
| |
 |
China plant has updated ISO 13458:2003 certificate (SX 60014694 0001) |
| |
 |
China plant has updated ISO 9001:2000 certificate (SY 60014695 0001) |
Q2 |
 |
China plant has updated Canada CMDCAS certificate (74 500 2402) |
|
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 has obtained Taiwan GMP certificate. |
|
Q3 |
|
TH00
series has 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 has 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 have 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 has obtained CANADA Medical Device
Licence |
|
|
|
(65574). |
|
|
 |
THXXN
Series have 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 has obtained Taiwan GMP certificate. |
|
|
 |
China
plant has obtained Canada CMDCAS certificate (74 500
2402). |
|
|
 |
China
plant upgraded ISO 13485 to version 2003 (SY 60008246
0001). |
|
|
 |
TH05F
has 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 has obtained Canada CMDCAS certificate (74 500
2402). |
|
|
 |
Taiwan
plant upgraded ISO 13485 to version 2003 (SY 60008246
0001). |
|
|
 |
Infrared
Ear Thermometer has obtained CANADA Medical Device Licence. |
| |
|
(63558) |
|
|
 |
Infrared
Forehead Thermometer has obtained CANADA Medical Device
Licence. |
| |
|
(63559) |
|
|
 |
TNT
series, comply with EMC test (AE 50040217 0001). |
| |
2003 |
|
Q4 |
 |
Taiwan
plant has obtained Canada CMDCAS certificate (74 500
2402). |
|
|
 |
China
plant has obtained Canada CMDCAS certificate (74 500
2402). |
|
Q3 |
 |
TH03F
has 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
has obtained the "Symbol of Excellence Awards"
from Taiwan |
| |
|
government.
|
|
 |
TN105
has obtained the "Symbol of Excellence Awards"
from Taiwan |
| |
|
government.
|
|
|
 |
TN2
series, comply with EMC test (AE 50023801 0001). |
|
|
 |
TH109
has obtained FDA approval (K030324). |
| |
2002 |
|
Q4 |
 |
TH109
has obtained CE approval (HD 60005278 0001). |
|
|
 |
TH839
has obtained CE approval (HD 60005278 0001). |
|
|
 |
TH839
has obtained FDA approval (K011059). |
|
|
 |
TN105
has 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 has obtained ISO 13485:1996 certificate. |
|
|
 |
China
plant has obtained ISO 9001:1994 certificate. |
|
|
 |
TH889
has 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 has obtained ISO 13485:1996 certificate. |
|
|
 |
Taiwan
plant has obtained ISO 9001:1994 certificate. |
|
 |
TH809
has obtained the "Symbol of Excellence Awards"
form Taiwan |
| |
|
government.
|
|
|
 |
TH889
has 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
has obtained FDA approval (K011059). |
|
Q1 |
 |
Taiwan
plant has obtained ISO 13485:1996 certificate. |
|
|
 |
Taiwan
plant has obtained ISO 9001:1994 certificate. |
|
|
 |
TH809
has obtained CE approval (HD 60005278 0001). |
| |
2000 |
|
Q3 |
|
Radiant
Innovation Inc. was established on Jun. 28, 2000 |