Test Obelis
Are you sure your products are classified as Medical Devices?
Yes
No
Are you currently shipping Medical Devices to Europe ?
Yes
No
Are you or do you intend to place Medical Devices on the EU market under your own name or trade name?
Yes
No
Do you own a factory and manufacture your own Medical Devices?
Yes
No
Do you have a Technical File for your Medical Devices?
Yes
No
Have your Labels and IFUs (Instructions for use) been reviewed by an EU organization or a consultant?
Yes
No
Do you hold ISO 9001:2008 or 13485:2012 certificates?
Yes
No
Were your Medical Devices registered anywhere in Europe?
Yes
No
Have you designated an Authorized Representative (EC REP)?
Yes
No
Have you designated a Notified Body (NB)?
Yes
No
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