Company Name
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Website address
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Address
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City
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Name and Intended Use
Name and intended use of the device.
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EU Class
Do you have any idea about how your device might be classified in the EU?
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
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