Company Name
*
Address
Street Address
*
Address continued
Postal Code
*
City
*
Website address
*
Contact Person
*
E-Mail
*
Does your company hold any active 510(k)s or PMAs for products on the US Market?
*
Yes
No
Name and Intended Use
Name and intended use of the device.
*
FDA Class
Do you have any idea about how your device might be classified by the FDA?
Device Information
Is this device an IVD
*
Yes
No
Is this device sterile?
*
Yes
No
Does this device use electrical power?
*
Yes
No
Does this device contain software?
*
Yes
No
Does this device contain any pharmaceutical agent?
*
Yes
No
Does this device contain any substance of animal or human origin?
*
Yes
No
Is this device intended to be used with other devices?
*
Yes
No
Is this device sold in the internet?
*
Yes
No
Does your company sell any devices on the internet?
*
Yes
No
Is your company ISO 13485 certified?
*
Yes
No
Comments/Questions
Additional comments may be made here.
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