| |
200620062006200620006020062008 |
Q2 |
 |
TCT30 Series have obtained NSF approval |
| |
|
(4R160-01 / 4R161-01). |
Q1 |
 |
TH6 Series have obtained CANADA Medical Device License
|
| |
|
(76199). |
|
 |
TN01U, comply with EMC test (AE 50125069 0001). |
| |
200620062006200620006020062007 |
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 has obtained FDA approval (K070976). |
|
 |
TH5 Series have 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). |
| |
200620062006200620000620062006 |
Q4 |
 |
TH5 Series have obtained CANADA Medical Device License
|
| |
|
(72498). |
|
 |
TH5 series have 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 have 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). |
| |
200620062006200620006020062005 |
|
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). |
| |
200620062006200620006020062004 |
|
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). |
| |
200620062006200620006200062003 |
|
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). |
| |
200620062006200620006200062002 |
|
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). |
| |
200620062006200620006200062001 |
|
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). |
| |
200620062006200620006200062000 |
|
Q3 |
|
Radiant
Innovation Inc. was established on Jun.
28, 2000 |