FDA US Agent Questionnaire
QNET Export Finance Services LLC needs certain information from you in order to prepare a proposal for services. This form is meant to help us identify your needs. All information provided will be treated as confidential.
Company Name*
WebSite address
Contact Name*
Email*
Address
City and Postal Code
Phone*
Company Details*
Brief description of your Company's activities.
Does your Company currently sell any devices on the Internet? *
Yes
No
Intended use of the Device *
Name and intended use of the device you plan to sell on the US market.
Is this device sold on the internet?*
Yes
No
Does your Company hold any active 510(k)s or PMAs for products on the US market? *
Yes
No
Classification in the US?
Do you have any idea about how your device might be classified in the US?
Is your device sterile? *
Yes
No
Is your device an In Vitro Diagnostic? *
Yes
No
Does your device use electrical power? *
Yes
No
Does your device contain software?*
Yes
No
Does your device contain any pharmaceutical agents? *
Yes
No
Does your device contain any substances of animal origin? *
Yes
No
Does your device contain any substances of human origin? *
Yes
No
Is your device intended for use with other products? *
Yes
No
Additional Comments
Provide any additional information about the device that maybe useful or relevant.