Last week, My team and I met the Thai FDA staffs about the import license. They said everything will almost done and request some additional documents.
Please see the attachment below:
Risk Analysis [2752CC, 2773MS].pdf
3 Interfacility Agreement FE 11-3-11.pdf
Letter of Explanation [2752CC, 2773MS].pdf
Intertek_EN_ISO13485-2012_Certificate_1055_B.pdf
ISO 13485 France (Certificate No. MED-0235).pdf
IEC 60601-1-2 (Report 3045869-27-1-3).pdf
Could you print out, sign and stamp the documents? and send them to us as soon as possible via my address below:
PIMWADEE PERMSOMBAT
UFAM CLINIQUE CO., LTD.
1296/69-71 KRUNGTHEP-NONTHABURI ROAD
BANGSUE, BANGSUE, BANGKOK
THAILAND 10800
For 2752 CC, We would like to ask you for preparing the documents.
There are:
Document of circuit diagram for 2752 CC
Material safety data sheet of ConductorTM Transmission Gel
Product's label or sample packaging of ConductorTM Transmission Gel
Another related document or relative document about ConductorTM Transmission Gel
Because ConductorTM Transmission Gel was included in the license of 2752 CC.
- Standard accessory: 4248 ConductorTM Transmission Gel- 250 ml Bottle
- Optional accessory: 4238 ConductorTM Transmission Gel-5 liter container
The Thai FDA staffs ask us for providing the document of this. So, you send the document to us for approval. We'll consult with Thai FDA staffs and inform you back.
We are looking forward to hearing from you.
Thank you very much for your help.
Pimwadee
Last week, My team and I met the Thai FDA staffs about the import license. They said everything will almost done and request some additional documents.
Please see the attachment below:
Risk Analysis [2752CC, 2773MS].pdf
3 Interfacility Agreement FE 11-3-11.pdf
Letter of Explanation [2752CC, 2773MS].pdf
Intertek_EN_ISO13485-2012_Certificate_1055_B.pdf
ISO 13485 France (Certificate No. MED-0235).pdf
IEC 60601-1-2 (Report 3045869-27-1-3).pdf
Could you print out, sign and stamp the documents? and send them to us as soon as possible via my address below:
PIMWADEE PERMSOMBAT
UFAM CLINIQUE CO., LTD.
1296/69-71 KRUNGTHEP-NONTHABURI ROAD
BANGSUE, BANGSUE, BANGKOK
THAILAND 10800
For 2752 CC, We would like to ask you for preparing the documents.
There are:
Document of circuit diagram for 2752 CC
Material safety data sheet of ConductorTM Transmission Gel
Product's label or sample packaging of ConductorTM Transmission Gel
Another related document or relative document about ConductorTM Transmission Gel
Because ConductorTM Transmission Gel was included in the license of 2752 CC.
- Standard accessory: 4248 ConductorTM Transmission Gel- 250 ml Bottle
- Optional accessory: 4238 ConductorTM Transmission Gel-5 liter container
The Thai FDA staffs ask us for providing the document of this. So, you send the document to us for approval. We'll consult with Thai FDA staffs and inform you back.
We are looking forward to hearing from you.
Thank you very much for your help.
Pimwadee
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